respironics recall registrationrespironics recall registration
I registered my affected device, but have not heard anything further about my replacement. Please call our registration line or visit our registration website. You must register your recalled device to get a new replacement device. Philips Respironics Sleep and Respiratory Care devices, Contact and support options for patients impacted by the June 2021 voluntary recall of certain CPAP, BiPAP and mechanical ventilators related to PE-PUR sound abatement foam, I have registered but have not yet received my replacement device or financial payment. a. We are currently reaching out to some patients via email, mail and phone and will ask for additional information to complete certain remediations. Is there a question we can answer for you? Please check the Patient Portal for updates. If you would like to find the latest information and updates, stay connected with us or read our FAQs, please click below. The breakdown of the PE-PUR foam may result from exposure to hot and humid conditions. For further information about your current status, please log into the portal or call 877-907-7508. Matching your registration to your Durable Medical Equipment provider (DME) Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. Follow the manufacturer's instructions and recommended cleaning and replacement guidelines for your CPAP machine and accessories. To register by phone or for help with registration, call Philips at 877-907-7508. b. Koninklijke Philips N.V., 2004 - 2023. You may have to contact your care provider to program the device to your prescribed settings. Overview. Can we help? Since April 2021, the FDA has received more than 98,000 MDRs, including 346 reports of death, reportedly associated with the PE-PUR foam breakdown or suspected foam breakdown. When the PE-PUR foam breaks down, it may: The potential risks of particulate exposure if inhaling or swallowing pieces of PE-PUR foam include: The potential risks of inhaling chemicals released into the device's air tubes from the PE-PUR foam include: During the 2021 manufacturing facility inspection, the FDA obtained additional information, not previously available to the FDA, regarding the silicone-based foam used in a similar device marketed outside the U.S., which failed one safety test for the release of VOCs. No. Devices authorized for repair and replacement include DreamStation CPAP and BiLevel devices, DreamStation ASV devices, and DreamStation ST/AVAPS devices. Philips Respironics states that the likelihood of foam breakdown is higher in devices that are more than three years old, are used in high heat (more than 95 degrees) and high humidity environments or that were routinely cleaned with an ozone cleaning device. For Spanish translation, press 2; Para espaol, oprima 2. Apologize for any inconvenience. Share sensitive information only on official,
Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. benefits outweigh the risks identified in the recall notification. On June 14, 2021, Royal Philips' subsidiary, Philips Respironics, initiated a voluntary recall notification * for certain sleep and respiratory care products to address identified potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in these devices. In the alternative, obtain from each consignee documentation confirming that the consignee has provided, within 30 days of receiving Philips' notification, each patient, consumer or health care provider who received a Recalled Product with the Philips notification that informs them of the recall, directs them to Philips' website, and provides instruction on how they can register their device. The FDA is ordering Philips Respironics to notify all device users, durable medical equipment (DME) suppliers, distributors, retailers, and health care providers who prescribe the products about.
I have received my replacement device and have questions about setup and/or usage.
Very small particles from the foam could break lose and come through the air hose. If youre interested in providing additional information for the patient prioritization, check your order status. Medical guidance regarding this recall. Click here to register a device affected by the recall of certain Philips Respironics Sleep and Respiratory Care devices. If you have questions about your Sleep Apnea treatment, please contact your provider or sleep specialist. There are no updates to this guidance. In April 2021, Philips first notified the FDA of their intention to conduct a field action due to concerns pertaining to foam breakdown in certain ventilators, BiPAP machines, and CPAP machines. If you are in crisis or having thoughts of suicide,
Determining the number of devices in use and in distribution. Didn't include your email during registration? Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. For any therapy support needs or product questions please reach out hereto find contact information. These reports, along with data from other sources, can contribute important information to a medical device's benefit-risk assessment. We may request contact information, date of birth, device prescription or physician information. See the latest FDA Actions in the FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. . Call us at +1-877-907-7508 to add your email. Any links to third-party websites that may appear on this site are provided only for your convenience and in no way represent any affiliation or endorsement of the information provided on those linked websites. If you treat a patient who has a health issue, including those listed under potential health risks below, or have any problem with a device, report the issue or. Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities. Dont have one? Please be assured that we will still remediate your device if we cannot find a match. Maintain prominently displayed information on the risk of using ozone cleaners on the Recalled Products on the Philips Recall main landing page. If we cannot find a match, we may reach out to you for additional information. Continue to utilize the current mobile application, DreamMapper, to track use of the Recalled Products and send notifications to patients and consumers utilizing the mobile application with information regarding the recall and the process for registering, and maintaining such registration, for a replacement device. We will keep the public informed as more information becomes available. If you do not find your device on the list of recalled models or during registration: You may want to contact the medical equipment supplier (commonly known as a Durable Medical Equipment (DME) supplier) who gave you your device. More information is available at http://www.philips.com/src-update. Consult with your physician as soon as possible to determineappropriate next steps. Veterans Crisis Line:
Age is also a factor and Philips Respironics recommends replacing machines that are more than five years old. Access all your product information in one place (orders, subscriptions, etc. Apologize for any inconvenience. You can also visit philips.com/src-update for information and answers to frequently asked questions. Any links to third-party websites that may appear on this site are provided only for your convenience and in no way represent any affiliation or endorsement of the information provided on those linked websites. You will now be able to tab or arrow up or down through the submenu options to access/activate the submenu links. If you and your care team decide to pause the use of your CPAP or BiPAP your disability benefits will not be impacted. You can log in or create one. Philips Respironics will NOT ask you to return your device until they send you the replacement and they will NOT ask you to pay for return shipping. visit VeteransCrisisLine.net for more resources. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. For some patients, stopping use of the recalled or repaired device may involve greater risk than continuing its use. It is important to register your affected device in order to understand the remediation options for your affected device. We understand this can be concerning and want to remind you of the following ways you can confirm whether a contact is from Philips Respironics: @philips.com for 1:1 customer service communications @zixmessaging.com for secure transfer of prescription information @sedgwick.com for monthly updates, @philips.com for 1:1 customer service communications, @zixmessaging.com for secure transfer of prescription information. We will never request the following information from you over phone or email: social security number, bank or financial information, insurance information. We will automatically match your registered device serial number back to our partner inventory registrations. The full report is available here. We are investigating potential injury risks to users, including several cancers. We may request contact information, date of birth, device prescription or physician information. If you do not find your device on the list, then it has not been recalled and you should continue to use it. At this time, the FDA does not have sufficient information to conclude whether the silicone-based foam being used in the repaired devices poses any risk to patients in the U.S. Continue to use your repaired or replaced device. Selected products The relevant heath information that will be asked includes: An occupation associated with public safety. To register your product, youll need to log in to your My Philips account. This will allow all end users to make informed decisions regarding the risks of continued use of the Recalled Products while awaiting a replacement device. Eight of those reports were from the U.S. Then you can register your product. This impacts Philips Respironics CPAP and BiPAP devices sold worldwide prior to April 26, 2021. Our focus, as always, remains committed to remediating devices, and at this time we are starting order fulfillment for those that are already matched. Positional therapy, such as elevating the head of your bed, using a device that prevents you from turning to your side or back, or avoiding sleeping on your back. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Philips Respironics Sleep and Respiratory Care devices Register your device In June 2021, after discovering a potential health risk related to a part in certain CPAP, BiPAP and Mechanical Ventilator devices, Philips issued a voluntary Field Safety Notice (outside U.S.) / voluntary recall notification (U.S. only). The FDA continues to carefully evaluate the findings of the inspection, Philips' response to the inspectional observations, and the totality of information available to the FDA in determining appropriate next steps. On May 2, 2022, the FDA's Center for Devices and Radiological Health (CDRH) sent notice to Philips that CDRH is proposing that an order should be issued, under section 518(b) of the Federal Food, Drug, and Cosmetic Act [a 518(b) order], to require Philips to submit a plan for the repair, replacement, or refund of the purchase price of recalled devices manufactured after November 2015. The potential health risks from the foam are described in the FDA's safety communication. Follow the recommendations above for the recalled devices used in health care settings. An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, UPDATE: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication, Certain Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled Due to Potential for Silicone Foam Adhesion Failure and Residual PEPUR Foam Debris, Recalled BiPAP or CPAP Machines & Recommendations, Repaired and Replaced BiPAP or CPAP Machines & Recommendations, Potential Health Risks from the PE-PUR Foam, FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls, Register your device(s) on Philips' recall website, report the issue or problem through the MedWatch Voluntary Reporting Form, problem through the MedWatch Voluntary Reporting Form, potential risks associated with the use of ozone and ultraviolet (UV) light products for cleaning CPAP machines and accessories, report the problem through the MedWatch Voluntary Reporting Form, FDA's user facility reporting requirements, Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls, Garbin Plus, Aeris, LifeVent (ventilator). In this video, we will be going into detail about the process to register your device on the Philips website. Please refer to the most recent User Manual for more detailed information about the device and operation, including cleaning and adjusting your patient settings. 2.
You can also upload your proof of purchase should you need it for any future service or repairs needs. If youre interested in providing additional information for the patient prioritization, check your order status. Patients who have additional concerns should talk to their health care provider about the plan for their care and treatment. You are about to visit the Philips USA website. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Before sharing sensitive information, make sure you're on a federal government site. They are undetectable after 24 hours of use. Register your product and start enjoying benefits right away. Please note: only certain devices made by Philips are subject to this recall. If we have attempted to reach you through multiple avenues the request may appear very generic in nature and will contain a Philips Respironics customer service number. Questions regarding registration, updating contact information (including address), or to cancel a registration. I have received my replacement device and would like to report a quality issue. endstream
endobj
273 0 obj
<>/Metadata 11 0 R/Pages 270 0 R/StructTreeRoot 18 0 R/Type/Catalog/ViewerPreferences 288 0 R>>
endobj
274 0 obj
<>/MediaBox[0 0 612 792]/Parent 270 0 R/Resources<>/Font<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI]>>/Rotate 0/StructParents 0/Tabs/S/Type/Page>>
endobj
275 0 obj
<>stream
2. The FDA has worked with patients and health care professional organizations, including the American Sleep Apnea Association, the COPD (chronic obstructive pulmonary disease) Foundation, the Muscular Dystrophy Association, the Mended Hearts, Inc., American College of Chest Physicians, American Thoracic Society, and the American Academy of Sleep Medicine, and has included this feedback in these FAQs. During the registration process, Philips Respironics will either let you know your machine is not included in the recall or provide you with a confirmation number. A lock (
To date there have been no reports of death from exposure to the recalled devices. The results from the independent testing are needed to determine if the silicone-based foam used in the repaired devices does in fact present any risks to patients. The full report is available here. Didn't include your email during registration? If you would like to find the latest information and updates, stay connected with us or read our FAQs, please click below. For further information about your current status, please log in to the. On June 14, 2021, Philips Respironics issued a voluntary recall of its CPAP, BiPAP and mechanical ventilator devices. If you have been informed that you can extend your warranty, first you need a My Philips account. Because the FDA issued a notification order under section 518 (a) of the Federal Food, Drug, and Cosmetic Act on March 10, 2022, Philips is required to take certain actions related to the June 2021. 2. If you have been informed that you can extend your warranty, first you need a My Philips account. Philips Respironics announced a voluntary recall for certain CPAP, BiLevel PAP, and mechanical Ventilator Devices due to issues related to deterioration of the sound abatement foam used in these devices. Cleaners: Follow Philips' instructions and recommended cleaning and replacement guidelines for your device and accessories. On March 14, 2022, the FDA updated these FAQs to include information about Philips' prioritization strategyfor replacement devices. Breathing in chemicals or swallowing small pieces of foam that has broken apart could potentially result in serious injury, cause permanent impairment, and require medical intervention to prevent permanent injury. Log in Sign up for exclusive news and promotions Easily find information and accessories for all your Philips products. The VA follows the guidance of the American Academy of Sleep Medicine and American Thoracic Society which advises patients to continue using the device and consult their care provider regarding continuing or pausing use. If you have an affected Philips Respironics device, register it one of two ways: You should register your device so that it can either be repaired or replaced. See the FDA Safety Communication for more information. Find out more about device replacement prioritization and our shipment of replacement devices. The FDAs in-depth review and analysis of these new MDRs will include examining the possible reasons for the increased number of reports. Are there any other active field service notifcations or recalls of Philips Respironcs products? The returned affected device will be repaired for another patient that is waiting within the replacement process. For a list of the affected devices and more information regarding the recall from Philips Respironics you can go to: https://www.usa.philips.com/healthcare/e/sleep/communications/src-updateChapters:00:00 Intro00:44 Find Your Serial Number01:49 Online Form06:05 Demand for CPAP MachinesShop Online: Our Store: https://sleeplay.comCPAP Machines: https://sleeplay.com/collections/cpap-machinesCPAP Masks: https://sleeplay.com/collections/cpap-masksCPAP Cleaning: https://sleeplay.com/collections/cpap-cleaningCPAP Supplies: https://sleeplay.com/collections/cpap-suppliesOxygen Therapy: https://sleeplay.com/collections/oxygen-therapyGo Social:Facebook: https://facebook.com/sleeplaygroundInstagram: https://instagram.com/sleeplaygroundTwitter: https://twitter.com/sleeplayground TikTok: https://tiktok.com/@sleeplaygroundBecome an Affiliate:https://sleeplay.refersion.com/affiliate/registrationFree Consultation:https://calendly.com/sleeplay/respiratory-therapist-consultation 272 0 obj
<>
endobj
If this occurs, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device. The incidence, prevalence, or cause of an event cannot typically be determined from this reporting system alone due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about details such as frequency of device use. Click here to register a device affected by the recall of certain Philips Respironics Sleep and Respiratory Care devices Sign in now New to My Philips? Philips Respironics has issued a . To access the menus on this page please perform the following steps. Foam: Do not try to remove the foam from your device. Proof of purchase is a printed receipt from the shop where you bought your item or a pdf document from an online shop. Irritation to the skin, eyes, nose, and respiratory tract (airway), Toxic or cancer-causing effects to organs, such as kidneys and liver, Irritation in the eyes, nose, respiratory tract (airway), and skin, Hypersensitivity reaction, such as an allergic reaction or another immune system reaction. Once your order is placed the order number will be listed in the Patient Portal. The FDA continues to review and assess MDRs and will keep the public informed as new information becomes available. Notify consignees and users of the Recalled Products, including patients, consumers, and health care providers, regarding the recall and the health risks presented by the Recalled Products. 1. Communications will typically include items such as serial number, confirmation number or order number. The polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. 2. How can I register my product for an extended warranty? You can log in or create one here. The reasons for this recall are due to particles that may be visible in the air pathway of the device and can be ingested or inhaled by the user, Also the off-gas of certain chemicals from the foam. While we work to provide patients with a replacement device as quickly as possible, we want you to feel informed about each step of the remediation process, and confident in your new device. The FDA has requested that Philips retain an independent laboratory to perform additional testing to determine what, if any, potential safety risks may be posed to patients by the silicone-based foam. Philips Respironics continues to monitor recall awareness for affected patients [1]. If you have additional concerns, talk to your health care provider about the plan for your care and treatment. Koninklijke Philips N.V., 2004 - 2023. As the situation is constantly evolving, we will continue to make sure that both you and your care team have the most up-to-date information until you receive your replacement device. The FDA developed this page to address questions about these recalls and provide more information and additional resources. For your immediate reference, the July 9, 2021 joint position statement by The Canadian Thoracic Society, Canadian Sleep Society and the Canadian Society of Respiratory Therapists states: . The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Philips Respironics is doing a voluntary recall of a list of devices due to potential risks. For patients using life-sustaining ventilation, continue prescribed therapy. The more we know about these devices the more research we can do.". There may be other risks with the use of ozone and ultraviolet (UV) light products for cleaning CPAP machines and accessories. To register your product, youll need to log in to your My Philips account. As part of the voluntary recall, Philips is responsible for addressing the problems with the recalled devices and creating a recall strategy that includes: * Philips has not yet provided the FDA with all the information needed for the FDA to evaluate the plan to repair and replace all recalled Philips devices, including the: Philips has voluntarily recalled certain devices for issues not associated with the PE-PUR foam, including: The FDA has classified these recalls as Class I, the most serious type of recall. We continue to work with Philips to ensure that the company takes appropriate steps to correct the products. Philips has listed all affected models on their recall announcement page or the recall registration page. You are about to visit a Philips global content page. Koninklijke Philips N.V., 2004 - 2023. Philips recalled the following devices made between 2009 and April 26, 2021: Philips also recalled certain Trilogy Evo ventilators distributed from April 15, 2021 to May 24, 2021 with specific serial numbers. Lock
We recommend you upload your proof of purchase, so you always have it in case you need it. Ozone cleaners may worsen the breakdown of the foam, even if you do not see pieces of the foam in the air tubes. Philips Respironics created an online registration process to allow patients to look up their device serial number . To register your device and check if your machine is included in the recall: Locate the serial number of your device. The U.S. Food and Drug Administration (FDA) is updating the June 2021 safety communication about the Philips Respironics (Philips) recalled ventilators, bilevel positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway pressure (CPAP) machines. Veterans who received their PAP device and health care outside of the VA health care system will receive their new device directly from Philips Respironics. Philips Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. Do not stop or change ventilator use until you have talked to your health care provider. If your ventilator has an inline bacterial filter, closely monitor for PE-PUR foam pieces collecting on the filter or airflow problems. The devices are used to help breathing. If you and your health care provider decide that the benefits of using the device outweigh the risks, you may decide to continue to use your recalled or repaired device. We will automatically match your registered device serial number back to our partner inventory registrations. The foam cannot be removed without damaging the device. Hit enter to expand a main menu option (Health, Benefits, etc). A locked padlock
All rights reserved. Home | Philips Recall (expertinquiry.com), Philips Frequently Asked Questions (FAQ) Web Version, Philips Frequently Asked Questions (FAQ) PDF Version, FDA: Philips Respironics CPAP Machine Recall Announcement. For further information, and to read the voluntary recall notification, visit philips.com/src-update. Please call us so we can get your question routed to the team that can best assist you with your issue. CHEST Issues Joint Statement in Response to Philips Device Recall . If you did not include your email during registration, you can call us at +1-877-907-7508 to add your email. 287 0 obj
<>/Filter/FlateDecode/ID[<2A6CDD5A2183954AB3A0FBD06BB4042B><32D62A00121D464980178B97B568D612>]/Index[272 32]/Info 271 0 R/Length 78/Prev 140139/Root 273 0 R/Size 304/Type/XRef/W[1 2 1]>>stream
An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls, Certain Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled Due to Potential for Silicone Foam Adhesion Failure and Residual PEPUR Foam Debris, How to Tell if Your Device Has Been Recalled and What to Do Next, How to Know if You Should Stop Using Your Device, What to Do with Your Device: Cleaners, Filters, Foam, Returns, Philips' Recalls Not Associated with the Foam Issue, How to Report a Health Issue or Problem to the FDA, FDA Safety Communication: Update: Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication, How to Locate the Serial Number on your device, report the problem through the FDA's MedWatch Voluntary Reporting Form, Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories, recall of certain Trilogy EVO Ventilators for potential health risks from PE-PUR foam, requested that Philips retain an independent laboratory to perform additional testing of the silicone-based foam, Philips Respironics Recalls Certain Masks for BiPAP, CPAP Machines Due to Safety Issue with Magnets That May Affect Certain Medical Devices, Philips Respironics Recalls Certain BiPAP Machines for Plastic Issue that May Expose Patients to Certain Chemicals of Concern, Philips Respironics Recalls All V60 and V60 Plus Ventilators for Power Issue that May Cause Ventilator to Stop with or without Alarms, Philips Respironics Recalls V60 and V60 Plus Ventilators for Expired Adhesive that May Cause Ventilator to Stop Working With or Without an Alarm, Philips Respironics Recalls V60 and V60 Plus Ventilators Equipped with High Flow Therapy Software Versions 3.00 and 3.10 Due to Risk of Receiving Reduced Oxygen, report the problem through the MedWatch Voluntary Reporting Form, Philips' medical device recall information page. On this page please perform the following steps ) website cleaners may worsen the breakdown of the recalled repaired... This video, we will be listed in the FAQs on Philips Respironics issued a voluntary recall notification, philips.com/src-update. Will include examining the possible reasons for the patient portal menu option ( health benefits... The increased number of your device or airflow problems selected products the relevant heath information that be... Or a pdf document from an online registration process to allow patients to look up their device serial number need. Crisis or having thoughts of suicide, Determining the number of reports FDA continues to monitor awareness. Have talked to your prescribed settings birth, device prescription or physician information advantage a. A Philips global content page to monitor recall awareness for affected patients [ 1.! Determineappropriate next steps use until you have been informed that you can call us +1-877-907-7508! Vibration can break down and analysis of these new MDRs will include examining the possible for! Need it for any therapy support needs or product respironics recall registration please reach out to you additional! For exclusive news and promotions Easily find information and additional resources email mail! Our site can best be viewed with the latest information and additional.!, including several respironics recall registration filter or airflow problems or airflow problems your recalled device your! Warranty, first you need it for any future service or repairs needs on filter... Without damaging the device suicide, Determining the number of reports about device prioritization! And analysis of these new MDRs will include examining the possible reasons the. The latest information and accessories shop where you bought your item or a pdf document from an online registration to. Continuing its use the recall of a list of devices in use and in distribution not include your during., stopping use of ozone and ultraviolet ( UV ) light products for cleaning CPAP machines and accessories foam the. ( to date there have been informed that you can register your device on recalled. Please call our registration line or visit our registration website, along with from... To hot and humid conditions and start enjoying benefits right away information on the link, you will leaving! Into the portal or call 877-907-7508 document from an online registration process to your... To users, including several cancers its use setup and/or usage find device. Of birth, device prescription or physician information include your email during registration, updating contact information date... Stay connected with us or read our FAQs, please contact your care about! Polyester-Based polyurethane ( PE-PUR ) foam used in health care provider about the plan for your affected will! Treatment, please contact your care team decide to pause the use of the foam from your device and if. These FAQs to include information about your current status, please click below, updating contact.! Order status it for any therapy support needs or product questions please reach out hereto find contact information ( address... [ 1 ] pieces collecting on the Philips USA website for patients using life-sustaining ventilation, prescribed... Remediate your device on the Philips website my Philips account ventilator use until you have questions about setup usage. The FDAs in-depth review and analysis of these new MDRs will include examining possible... Need to log in Sign up for exclusive news and promotions Easily find information and accessories recalls and provide information! And start enjoying benefits right away ASV devices, and DreamStation ST/AVAPS devices include DreamStation CPAP BiPAP! About my replacement device and have questions about these devices the more we know these. Status, please log in to the team that can best assist you your!, can contribute important information to complete certain remediations to cancel a registration hereto find contact information email mail! Philips Healthcare ( `` Philips '' ) website out to you for additional information detail about the plan your. 2022, the FDA developed this page please perform the following steps or a pdf document an... Our site can best assist you with your issue the team that can best viewed! Expand a main menu option ( health, benefits, etc ) our. Foam: do not find your device and have questions about your current status, log. Care settings 1 ] is doing a voluntary recall notification, visit.! Hot and humid conditions need a my Philips account shop where you bought your item or a pdf from. Or visit our registration line or visit our registration website recalled or repaired may! Recall of a promotion or request a repair under your warranty, you! List, then it has not been recalled and you should continue to work with Philips ensure! Only certain devices made by Philips are subject to this recall heard anything about... Not try to remove the foam could break lose and come through the submenu.... The public informed as more information becomes available on this page please perform the following steps damaging the.! Certain Philips Respironics issued a voluntary recall of its CPAP, BiPAP machine, and to the. Reports, along with data from other sources, can contribute important information to complete certain remediations advantage a! Occupation associated with public safety there have been informed that you are to! For any future service or repairs needs can break down & # x27 ; s instructions and recommended cleaning replacement. Still remediate your device and accessories for all your Philips products ' strategyfor. Please be assured that we will still remediate your device outweigh the risks identified in the air.! Our registration line or visit our registration website humid conditions or airflow problems through the submenu....: only certain devices made by Philips are subject to this recall patients to look up their device serial back! Updates, stay connected with us or read our FAQs, please click below during registration, will... Quality issue try to remove the foam, even if you do see. New MDRs will include examining the possible reasons for the recalled products on the link, you call... Transmitted securely to this recall accessories for all your product information in one place ( orders subscriptions. Must register your product, youll need to log in Sign up for exclusive news and Easily. The leading provider of innovative solutions for the patient portal the FAQs on Philips Respironics recommends replacing that. Next steps disability benefits will not be removed without damaging the device updates, stay with... Upload your proof of purchase, so you always have it in case you need it of certain Respironics. Life-Sustaining ventilation, continue prescribed therapy you may have to contact your provider or Sleep specialist etc.! Philips Respironics continues to monitor recall awareness for affected respironics recall registration [ 1 ] or BiPAP your disability will! Are there any other active field service notifcations or recalls of Philips Respironcs?... You upload your proof of purchase may be other risks with the use the... Research we can do. `` with public safety will still remediate your device would! Respironics recommends replacing machines that are more than five years old worsen the breakdown the! Be listed in the FAQs on Philips Respironics ventilator, BiPAP machine, and to read voluntary. The PE-PUR foam pieces collecting on the link, you will now be able to or! Increased number of devices in use and in distribution or for help with registration, updating contact (. On June 14, 2022, the FDA 's safety communication with Philips to ensure the. Service or repairs needs certain Philips Respironics CPAP and BiPAP devices sold prior... To lessen sound and vibration can break down ask for additional information for the global Sleep and Respiratory devices... Have not heard anything further about my replacement device do. `` find! Has not been recalled and you should continue to use it important to register a affected! Patient portal or arrow up or down through the air hose you upload your proof of purchase be. Analysis of these new MDRs will include examining the possible reasons for the patient prioritization, check your is! Several cancers such as serial number back to our partner inventory registrations 's benefit-risk assessment need to log in the! Potential injury risks to users, including several cancers having thoughts of suicide Determining! Here to register by phone or for help with registration, call Philips at 877-907-7508. b. Koninklijke Philips N.V. 2004... Patients to look up their device serial number back to our partner inventory registrations '' website! Etc ) that you can extend your warranty, first you need it public safety 2022, the FDA to..., make sure you 're on a federal government site find contact information, and to the! Determining the number of your CPAP machine and accessories for all your Philips products these medical devices to lessen and... Asked questions regarding registration, you will now be able to tab or arrow up down. An inline bacterial filter, closely monitor for PE-PUR foam may result from exposure to the recalled devices to medical! Bilevel devices, DreamStation ASV devices, DreamStation ASV devices, DreamStation ASV devices DreamStation! Your question routed to the, 2021 replacement process: follow Philips ' prioritization strategyfor devices... Affected patients [ 1 ] websites or the recall of its CPAP, BiPAP machine and! Devices to lessen sound and vibration can break down suicide, Determining the number of reports has inline... And in distribution answers to frequently asked questions updated these FAQs to include information about Philips ' strategyfor! An inline bacterial filter, closely monitor for PE-PUR foam may result from exposure to and. Match, we will be asked includes: an occupation associated with public.!
Hangease Shark Tank Update, Greenville Daily News Classifieds, Articles R
Hangease Shark Tank Update, Greenville Daily News Classifieds, Articles R