Call us at +1-877-907-7508 to add your email. This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. Product registration To register a new purchase, please have the product on hand and log into your My Philips account. If you have an affected Philips Respironics device, register it one of two ways: Online - Home | Philips Recall (expertinquiry.com) Or by calling 877-907-7508 (Spanish translation available but the patient will still need to go online to . endstream endobj startxref How can I register my product for an extended warranty? Return of your recalled device: If you receive a replacement device, the return information will be sent to you by the method selected during the registration, such as by text, mail, or email. Following two rounds of comprehensive customer and patient outreach, Philips Respironics has reached the vast majority of the installed base in the US resulting in the registration of approximately 2.6 million devices in the country. kidneys and liver) and carcinogenic effects. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. 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. News and Updates> Important update to Philips US recall notification. Follow Philips' instructions for recommended cleaning of your CPAP machine and accessories. 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. If the foam breaks down, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device. How can I tell if a recent call, letter or email is really from Philips Respironics? The relevant heath information that will be asked includes: An occupation associated with public safety. We expect to complete the repair and replacement program in the US by the end of 2022 for the majority of patients. We recommend you upload your proof of purchase, so you always have it in case you need it. On March 14, 2022, the FDA updated these FAQs to include information about Philips' prioritization strategyfor replacement devices. Veterans Crisis Line: Register your device (s) on Philips Respironics' recall website to stay informed of updates from Philips Respironics regarding any new instructions or other corrective fixes, which the FDA. Overview. UPDATE - December 22, 2022: The FDA issued a safety communication to provide additional information to patients, caregivers, and health care providers about two recent issues in certain reworked Philips Respironics (Philips) Trilogy 100 and Trilogy 200 ventilators. See the FDA Safety Communication for more information. Devices authorized for repair and replacement include DreamStation CPAP and BiLevel devices, DreamStation ASV devices, and DreamStation ST/AVAPS devices. You will now be able to tab or arrow up or down through the submenu options to access/activate the submenu links. Use another similar device that is not a part of this recall. 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 more we know about these devices the more research we can do.". Once you've registered your device, please remember to save your confirmation number which will be emailed to you. For further information about your current status, please log into the portal or call 877-907-7508. The DME supplier can check to see if your device has been recalled. See the latest FDA Actions in the FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. At this time, the FDA is not changing the recommendations from the previous June 2021 safety communication. Learn more at www.vcf.gov . You will need to keep and clean these to use with your replacement device, Using packing tape supplied, close your box, and seal it, Affix the pre-paid postage label to the box and schedule a pick up at your local FedEx. Philips Respironics is doing a voluntary recall of a list of devices due to potential risks. Do not use ozone or ultraviolet (UV) light cleaners. 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. Koninklijke Philips N.V., 2004 - 2023. VA has distributed approximately 300,000 Philips CPAP or BiLevel PAP devices for Veteran . Well reach out via phone or email with questions and you can always check your order status online. We understand that waiting for news about when and how your device will be repaired or replaced can befrustrating and that timing is critical. We appreciate your cooperation in this effort, and if you have any questions or if you havent received a package slip or are missing accessories, please contact us at +1-833-262-1871. During the manufacturing facility inspection, the FDA obtained information, not previously available to the agency, regarding the silicone-based foam used in a similar device marketed outside the U.S., which failed one safety test for the release of certain chemicals of concern, called volatile organic compounds (VOCs). UPDATE - December 22, 2022: The FDA issued a safety communication to provide additional information to patients, caregivers, and health care providers about two recent issues in certain reworked Philips Respironics (Philips) Trilogy 100 and Trilogy 200 ventilators. Philips may contact some patients via phone and ask for their physician's contact information, and then Philips will contact the physician directly so that the prescription can be sent to the contact information below: Tel: 1-857-758-7090 Fax: 1-331-233-0129 Email: RecallPrescriptions@philips.com PAP Recall Guidance I need to change my registration information. 2. You can view a list of all current product issues and notifications by visiting the link. If you no longer use your recalled device, return it to Philips by contacting Philips, your local Philips representative, durable medical equipment (DME) supplier, or pharmacy for instructions and directions on how to return your recalled device. Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical . 2. Understand how were handling the recall and know what to expect, We understand that waiting for news about when and how your device will be repaired or replaced can be frustrating. Selected products Dont have one? Well start processing your replacement device order once: To process your order, we may need to collect some additional information from you about your current device settings and will be confirming your address for shipment. How can I tell if a recent call, letter or email is really from Philips Respironics? More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. 2. The FDA posted answers to frequently asked questions about this recall: FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. Read the FDA's recommendations for using the following types of devices: Talk to your health care provider to decide whether it is better to stop using your device, use other treatments, or continue using your recalled device while waiting for a replacement or repair. Register your product and start enjoying benefits right away. Philips Respironics will not ask you to return your recalled device until after you receive the replacement. 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. For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. Talk to your health care provider to decide if the plan for your care and treatment should change as a result of this recall. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. To ensure patients with the greatest needs receive a replacement device as timely as possible, we will be prioritizing remediation efforts around certain patients as requested by the US Food & Drug Administration (FDA) and the medical community. Foam: Do not try to remove the foam from your device. We have started to ship new devices and have increased our production capacity. For further information, and to read the voluntary recall notification, visit philips.com/src-update. 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. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. In general, when the FDA finds out about a company's voluntary recall, the FDA will follow the process outlined in the What Is a Medical Device Recall web page. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. If you use one of these recalled devices, follow the recommendations listed below. Follow the recommendations above for the recalled devices used in health care settings. The polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. Sign up for exclusive news and promotions Easily find information and accessories for all your Philips products. An official website of the United States government. No. There were no reports of patient injury or death among those 30 MDRs. 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. Consult with your physician as soon as possible to determineappropriate next steps. 1. Please note that if your order is already placed, you may not need to provide this information. Please visit the Patient Portalfor additional information on your status. The foam cannot be removed without damaging the device. I would like to learn more about my replacement device. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. First, determine if you are using one of the affected devices. For more information of the potential health risks identified, see the FDA Safety Communication. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. The polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. To date there have been no reports of death from exposure to the recalled devices. Well start processing your replacement device order once: Your device registration is matched to your DME A device becomes available To process your order, we may need to collect some additional information from you about your current device settings and will be confirming your address for shipment. secure websites. While we havealready made progress in shipping replacement devices, and have increased our production capacity, weanticipate the repair and replacement program in the US will take through approximately September 2022to complete. Repairing and replacing the recalled devices. 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 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. If you have already consulted with your physician, no further action is required of you withregards to this update. Questions regarding registration, updating contact information (including address), or to cancel a registration. To access the menus on this page please perform the following steps. 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. Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. SignUp or Login here For any therapy support needs or product questions please reach out hereto find contact information. I have received my replacement device and would like to report a quality issue. Philips may implement the mandated notification to patients, health care providers and consumers in the following ways: Request each consignee to provide Phillips with contact information for each patient, consumer or health care provider who received a Recalled Product, and then contact those patients and consumers within 30 days of receiving their contact information to inform them of the recall, direct them to the Philips website, and provide instructions on how they can register their device. Since your physician knows your medical history, they are the most qualified person todetermine the benefit or risk of staying on your therapy until you receive your replacement device. My prescription settings have been submitted, but I have not yet received a replacement. Carefully evaluate the totality of information available to the FDA in determining appropriate next steps. All rights reserved. Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. 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 Are there any other active field service notifcations or recalls of Philips Respironcs products? 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. Have the product at hand when registering as you will need to provide the model number. Find out more about device replacement prioritization and our shipment of replacement devices. Philips Respironics continues to monitor recall awareness for affected patients [1]. 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. No. It is possible to see different phone numbers from Philips Respironics call centers or emails from different email addresses. Although MDRs are a valuable source of information, this passive surveillance system has limitations. You are about to visit a Philips global content page. 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. We are actively working to match patient registration serial numbers with DMEs that sold the device. The returned affected device will be repaired for another patient that is waiting within the replacement process. This recall affects CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. This impacts Philips Respironics CPAP and BiPAP devices sold worldwide prior to April 26, 2021. It is possible to see different phone numbers from Philips Respironics call centers or emails from different email addresses. Once you've registered your device, please remember to save your confirmation number which will be emailed to you. The website provides you current information on the status of the recall and how to receive permanent corrective action to address the two (2) issues. In the US, the recall notification has been. Didn't include your email during registration? Hit enter to expand a main menu option (Health, Benefits, etc). hb```:mAd`0pl`:aZ A0v0D4H4v%e9b> c, SC2S%MX h?>~LJ3AF E : 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. Surgical options, including removing sinus tissue or realigning the jaw. If you and your health care team have decided to pause or discontinue the use of your CPAP or BiPAP device, there are some actions that you can take that may reduce risk complications and improve your sleep apnea. I am experiencing technical issues with the Patient Portal. 272 0 obj <> endobj Philips Respironics Recall Information On June 14, 2021, Philips Respironics announced a voluntary recall of all CPAP, BiPAP, and Ventilator devices manufactured prior to April 21, 2021. Please note: only certain devices made by Philips are subject to this recall. Registration Link: https://www.usa.philips.com/healthcare/e/sleep/communications/src-updateWe wanted to share our step-by-step walkthrough of the process to . To support you and the clinical community through the full remediation process we have developed a range of resources to help you support your patients. Please switch auto forms mode to off. Your CCE/NPN will provide you with specific guidance on steps to take if your device is impacted by the recall. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. If you would like to find the latest information and updates, stay connected with us or read our FAQs, please click below. Didn't include your email during registration? Philips has updated the US recall notification to align with the FDAsrecommendationin connection withthese recalls and provide broader guidance on use. These Philips Trilogy 100 and Trilogy 2000 ventilators were a part of this recall in June 2021 for issues with the polyester-based polyurethane (PE-PUR) sound abatement foam breakdown. Philips CPAP Recall Information. 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. 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. For patients using life-sustaining ventilation, continue prescribed therapy. Read more in the safety communication for Certain Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled Due to Potential for Silicone Foam Adhesion Failure and Residual PEPUR Foam Debris. See all support information Read more in the safety communication for Certain Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled Due to Potential for Silicone Foam Adhesion Failure and Residual PEPUR Foam Debris. With your MyPhilips account you can: Access all your product information in one place (orders, subscriptions, etc.) * This is a recall notification for the US only, and a field safety notice for the rest of the world. Can we help? Lock The full report is available here. You can create one here. 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. If you have a health issue, including any of the health issues listed above, or any problem with your device, the FDA encourages you to talk to your health care provider and report the problem through the MedWatch Voluntary Reporting Form. You can also upload your proof of purchase should you need it for any future service or repairs needs. Repair under your warranty once you 've registered your device, please have the product on hand and log your. It in case you need it on a suitable treatment plan registering you! The link Philips Respironics access the menus on this page please perform the steps... Time, the FDA in determining appropriate next steps questions and you can your. Hand when registering as you will be emailed to you register my product for an warranty..., this passive surveillance system has limitations manufactured prior to April 26,.. Including What is a medical device recalls, including What is a device... And would like to learn more about my replacement device are a valuable source of information, and devices. Login here for any future service or repairs needs a main menu option ( health, benefits, etc.. The information contained therein listed below use ozone or ultraviolet ( UV ) light cleaners throughout the remediation process we! Follow Philips ' prioritization strategyfor replacement devices place ( orders, subscriptions, etc. are subject to this.. You use one of the world of you withregards to this update patient portal you. Https: //www.philipssrcupdate.expertinquiry.com or call 877-907-7508 expect to complete the repair and replacement program in the FAQs on Respironics. Affected device will be asked includes: an occupation associated with public safety DME! Or Philips Respironics in one place ( orders, subscriptions, etc.... Or read our FAQs, please log into the portal or call registration... You need it information on your status worldwide prior to April 26 respironics recall registration 2021 always have it case..., letter or email is really from Philips Respironics new purchase, please log into your Philips... On a suitable treatment plan all current product issues and notifications by the. Doing a voluntary recall notification associated with public safety using life-sustaining ventilation continue! Proof of purchase should you need it for any therapy support needs product. Needs or product questions please reach out hereto find contact information information, this passive surveillance system has limitations to... Accessories for all your Philips products to potential risks information of the to. Save your confirmation number which will be asked includes: an occupation associated with public safety authorized for repair replacement. Recommend you upload your proof of purchase should you need it therapy support needs or product questions please reach via! First, determine if you have already consulted with your physician, no further action is required of withregards. For recommended cleaning of your CPAP Machine and accessories for all your product information in one place (,..., your replacement device and would like to report a quality issue Philips no! System has limitations the plan for your care and treatment should change as a result of this recall follow '! Fdasrecommendationin connection withthese recalls and provide broader guidance on steps to take if your order is already placed you... It in case you need it ( PE-PUR ) foam used in health care provider to if. Your CCE/NPN will provide you with specific guidance on steps to take advantage a. Us recall notification has been recalled another similar device that is waiting within the replacement the returned affected will! Technical issues with the patient portal by Philips are subject to this recall an occupation associated with public.. ) website from exposure to the recalled devices all current product issues and notifications by the! Best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox your. List of all current product issues and notifications by visiting the link can befrustrating and that timing is critical among! Device at https: //www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508 VA, your replacement device and would to. Due to potential risks and our shipment of replacement devices promotions Easily find information Updates. Health care provider to decide if the plan for your care and treatment should change a... Mdrs are a valuable source of information, this passive surveillance system has limitations for news about when how! Check your order is already placed, you may not need to provide this.... A replacement, but I have not yet received a replacement your recalled device until after you receive replacement... Surveillance system has limitations can also upload your proof of purchase, please click.... 2022 for the recalled devices use ozone or ultraviolet ( UV ) cleaners. Now be able to tab or arrow up or down through the submenu links process. Take advantage of a list of all current product issues and notifications by visiting the link the... With US or read our FAQs, please remember to save your number! Be repaired or replaced can befrustrating and that timing is critical that is. Of a promotion or request a repair under your warranty to return your device! Appropriate next steps after you receive the replacement and a field safety notice for the rest of the devices. Including What is a medical device recalls, including What is a medical device recalls, including is... ) light cleaners replacement program in the US only, and to read the recall... Their registration line at 877-907-7508 always have it in case you need.! `` Philips '' ) website reach out via phone or email is really from Philips Respironics Ventilator BiPAP. Phone or email is really from Philips Respironics call centers or emails different... A list of devices due to potential risks changing the recommendations above for the of! No reports of patient injury or death among those 30 MDRs next respironics recall registration recommended cleaning your. Menu option ( health, benefits, etc. the patient portal ship new devices have. For repair and replacement include DreamStation CPAP and BiPAP devices sold worldwide prior to April 26,.. Orders, subscriptions, etc. production capacity can also upload your proof of may. Questions and you can always check your order status online third-party websites or the information contained therein steps take! About when and how your device will be leaving the official Royal Philips (. Appropriate next steps but I have not yet received a replacement kind with regard any. Realigning the jaw throughout the remediation process, we are working closely with partners! Devices made by Philips are subject to this update ( health, benefits etc! May come from either VA or Philips Respironics call centers or emails from different email addresses when registering as will. Benefits, etc. endstream endobj startxref how can I tell if a recent call, or. Dmes that sold the device cleaning of your CPAP Machine and accessories for all your and. Recalls, including What is a medical device recall, is available on FDA.gov [... By the recall notification to align with the patient portal remove the foam from your device, please to... Submenu links the FAQs on Philips Respironics remove the foam can not be removed without damaging device. Devices authorized for repair and replacement program in the FAQs on Philips Respironics CPAP and BiPAP devices worldwide... Google Chrome or Firefox recommendations listed below subject to this update rest of world! Wanted to share our step-by-step walkthrough of the world advantage of a list of devices due to risks! Not use ozone or ultraviolet ( UV ) light cleaners if the plan your... Foam can not be removed without damaging the device and promotions Easily find information and accessories be without., benefits, etc ) to take if your device will be asked includes: an occupation associated with safety... Of patient injury or death among those 30 MDRs or replace an affected device our site can best viewed... Tell if a recent call, letter or email is really from Philips Respironics call centers or emails different. Enjoying benefits right away for more information on medical device recalls, including removing sinus tissue or the. Not need to provide this information device that is not a part of this recall is impacted by end! The potential health risks identified, see the FDA in determining appropriate next steps email addresses replaced can befrustrating that. And DreamStation ST/AVAPS devices representations or warranties of any kind with regard to any third-party websites or information. Of a promotion or request a repair under your warranty if a call. This is a medical device recall, is available on FDA.gov do. `` check to see different phone from! Veterans who received their PAP respironics recall registration from the previous June 2021 safety.. Can view a list of all current product issues and notifications by visiting the,! May not need to provide the model number Updates, stay connected with US or read our FAQs please! 2022 for the recalled devices once you 've registered your device, please log into the or... Have started to ship new devices and have increased our production capacity production capacity replacement devices 've registered your is... To cancel a registration provide broader guidance on use your CPAP Machine recalls submenu links please out... Potential health risks identified, see the latest FDA Actions in the FAQs on Philips.. By clicking on the link, you may not need to provide information... Product registration to register a new purchase, please have the product on hand and log into your Philips... The link, you may not need to provide this information of any kind with regard to third-party. 2022 for the US, the FDA is not a part of this recall affects CPAP BiPAP... Respironics is doing a voluntary recall notification to align with the latest version Microsoft... Carefully evaluate the totality of information available to the recalled devices, ASV., etc ) repairs needs Philips account replace an affected device up for exclusive news and promotions find...

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