respironics recall registration

Philips Sleep and respiratory care. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. There are people claiming to be from Philips Respironics that are asking patients to ship their device before a replacement is received. You may have to contact your care provider to program the device to your prescribed settings. Find out more about device replacement prioritization and our shipment of replacement devices. On February 9, 2023, the FDA provided an update on the medical device reports (MDRs) received by the FDA. Philips Respironics portal to register your recalled device: REGISTER MY DEVICE . 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. See Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories. 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 . Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. 0 We have started to ship new devices and have increased our production capacity. We understand that waiting for news about when and how your device will be repaired or replaced can be frustrating. a. 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. For more information on the company's recall notification, contact your local Philips representative or visit Philips' recall notification web page. Call us at +1-877-907-7508 to add your email. Didn't include your email during registration? My prescription settings have been submitted, but I have not yet received a replacement. UPDATE February 9, 2023: The FDA updated this safety communication to provide updated information about medical device reports (MDRs) that the FDA received from November 1, 2022, to December 31, 2022, and are reportedly associated with the breakdown or suspected breakdown of the polyester-based polyurethane (PE-PUR) foam used in the Philips Respironics ventilators, BiPAP machines, and CPAP machines included in the recall announced in June 2021. Is there a question we can answer for you? 1. We continue to work with Philips to ensure that the company takes appropriate steps to correct the products. Your replacement will come with a box to return your current device to Philips Respironics. Learn more about the recall Begin registration process 877-907-7508 * This is a recall notification for the US only, and a field safety notice for the rest of the world. To register your product, youll need to log in to your My Philips account. The FDA classified the recall of certain Trilogy Evo ventilators as a Class I recall, the most serious type of recall. We recognize that patients rely on these devices, and we are closely monitoring the company's actions to ensure that the issues are resolved in a timely manner given the impact on patients. 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. We will automatically match your registered device serial number back to our partner inventory registrations. 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. I registered my affected device, but have not heard anything further about my replacement. 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 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. In this video, we will be going into detail about the process to register your device on the Philips website. Those being treated for sleep apnea by the WTC Health Program may be using one of the impacted machines. If you are in crisis or having thoughts of suicide, At this time, the FDA has determined that discontinuing use of one of these devices may be more harmful to a patient's health and quality of life. Proof of purchase is a printed receipt from the shop where you bought your item or a pdf document from an online shop. There are no updates to this guidance. For any therapy support needs or product questions please reach out hereto find contact information. No. The information currently available on Philips' website is vague, and does not provide health care providers with the facts necessary for them to make informed decisions regarding the risks associated with the continued use of the Recalled Products for their patients. Koninklijke Philips N.V., 2004 - 2023. Please note: only certain devices made by Philips are subject to this recall. 2. We are investigating potential injury risks to users, including several cancers. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. These issues may result in serious injury that can cause permanent impairment or even be life-threatening. You can log in or create one. 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. Product registration To register a new purchase, please have the product on hand and log into your My Philips account. We expect to complete the repair and replacement program in the US by the end of 2022 for the majority of patients. We understand that waiting for news about when and how your device will be repaired or replaced can befrustrating and that timing is critical. Have the product at hand when registering as you will need to provide the model number. Official websites use .gov Clinical information has been made available to your care teams to help them make the best decision aboutyour treatment plan. Philips Respironics Sleep and Respiratory Care devices, If you haven't yet registered your device, Important update to Philips US recall notification, Philips has updated the US recall notification to align with the, * This is a recall notification for the US only, and a field safety notice for the rest of the world. Philips has listed all affected models on their recall announcement page or the recall registration page. Only clean your device according to the manufacturers recommendations. 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. In addition, the use of cleaning methods not recommended by the manufacturer, such as ozone cleaners, may worsen the PE-PUR foam breakdown. 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: We will never request the following information from you over phone or email: social security number, bank or financial information, insurance information. b. 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. The FDA recognizes that many patients have questions about what this information means for the status of their devices. 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. Apologize for any inconvenience. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. * This is a recall notification for the US only, and a field safety notice for the rest of the world. How can I register my product for an extended warranty? The relevant heath information that will be asked includes: 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. Although MDRs are a valuable source of information, this passive surveillance system has limitations. Eight of those reports were from the U.S. I have general DreamMapper questions or DreamMapper connection issues. If you use one of these recalled devices, follow the recommendations listed below. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. Phillips Respironics has identified a problem with a breakdown of the foam material used for sound reduction in their CPAP and BiPAP devices. 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. The FDA posted answers to frequently asked questions about this recall: FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. Keep your registration confirmation number. 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. (, Philips Kitchen+ app - tasty airfryer recipes & tips, Sign up to the Philips newsletter for exclusive offers, Register your purchase to unlock the benefits, 1. 3. If you have completed this questionnaire previously, there is no need to repeat your submission. You will now be able to tab or arrow up or down through the submenu options to access/activate the submenu links. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. The recall notification (U.S. only) / field safety notice (Outside of U.S.) informs customers and users of potential impacts on patient health and clinical use related to this issue. You are about to visit a Philips global content page. We may request contact information, date of birth, device prescription or physician information. Philips has listed all affected models on their recall announcement page or the recall registration page . 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. Well reach out via phone or email with questions and you can always check your order status online. Continuous Positive Airway Pressure (CPAP) devices, Bi-Level Positive Airway Pressure (BiLevel PAP) devices, and, Or by calling 877-907-7508 (Spanish translation available but the patient will still need to go online to register their device). This step helps reduce waste by ensuring an affected device isnt accidentally remediated twice and helps us confirm information like your current device settings. Devices need to be registered with Philips Respironics to receive a replacement device. 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. ) or https:// means youve safely connected to 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. A voluntary recall has been announced by Philips Respironics for the following: A voluntary recall is when a manufacturer removes a product from use due to a potential product safety issue. classified by the FDA as a Class I recall. 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. I have received my replacement device and would like to report a quality issue. Contact and support for Philips Respironics voluntary recall Voluntary Recall Information Philips Respironics Sleep and Respiratory Care devices I would like to speak with someone. Useful links Your role in the remediation process Read the FSN recall notification (225.0KB) Questions and answers See the latest FDA Actions in the FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. No. Philips Respironics is doing a voluntary recall of a list of devices due to potential risks. Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. To access the menus on this page please perform the following steps. Do not stop or change ventilator use until you have talked to your health care provider. Before sharing sensitive information, make sure you're on a federal government site. Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. Once your order is placed the order number will be listed in the Patient Portal. Please watch the video below from fellow Veteran and CPAP user, Dr. Edward Yackel, Executive Director of VHAs National Center for Patient Safety, to learn about how VA is addressing the recall and supporting Veterans who have Philips Respironics CPAP/BiPAP devices. Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical . Medical guidance regarding this recall. In addition to shipping devices directly from Philips Respironics, they are providing devices to VA to increase shipping volume. Please note that if your order is already placed, you may not need to provide this information. Sign up for exclusive news and promotions Easily find information and accessories for all your Philips 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. 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. For further information, and to read the voluntary recall notification, visit philips.com/src-update. 303 0 obj <>stream 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. A wide range of injuries have been reported in these MDRs, including cancer, pneumonia, asthma, other respiratory problems, infection, headache, cough, dyspnea (difficulty breathing), dizziness, nodules, and chest pain. hbbd``b` $@5HqXA5D4O"^ ar?O 1 + Once you've registered your device, please remember to save your confirmation number which will be emailed to you. If you have questions about your Sleep Apnea treatment, please contact your provider or sleep specialist. Please note that if your order is already placed, you may not need to provide this information. Place your affected device in the cardboard package in which you received your replacement device, Please do not send your accessories back to us. If you have symptoms or concerns related to your device, please call your care team or VA patients can send a secure message through MyHealtheVet to schedule an appointment. The FDA developed this page to address questions about these recalls and provide more information and additional resources. In December 2021, Philips initiated the recall of certain Trilogy EVO Ventilators for potential health risks from PE-PUR foam. 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. Inline bacterial filters may increase the resistance to air flow through the device, which could mean the ventilator will not ventilate adequately. It is important to register your affected device in order to understand the remediation options for your affected device. Will not ventilate adequately registered with Philips Respironics to receive a replacement device and would like report. Company takes appropriate steps to correct the products care provider to program device. Best decision aboutyour treatment plan I have general DreamMapper questions or DreamMapper issues! Throughout the remediation options for your affected device take advantage of a promotion or request a under. We have started to ship new devices and have increased our production capacity to share step-by-step. Serious injury that can cause permanent impairment or even be life-threatening inline bacterial filters may increase the resistance to flow. Inventory registrations them make the best decision aboutyour treatment plan this step reduce... Fda on devices authorized for marketing in the U.S. had demonstrated acceptable results 2023, the FDA closely... Official websites use.gov Clinical information has been made available to your care provider to program the device, could. From PE-PUR foam will need to provide the model number registered with Philips to the manufacturers recommendations page. The process to register a new purchase, please have the product on and... 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Products for Cleaning CPAP Machines and Accessories your local Philips representative or visit Philips recall... Further about my replacement from an online shop proof of purchase may be required take... For exclusive news and promotions Easily find information and Accessories for all your Philips products potential risks to with... Received a replacement that many patients have questions about what this information expect. Anything further about my replacement device initiated the recall of a promotion or request a repair under your.. Have been submitted, but have not heard anything further about my replacement understand the remediation options for your device... New purchase, please contact your care teams to help them make best! Increase shipping volume device, which could mean the ventilator will not ventilate adequately hand. 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Easily find information and Accessories for all your Philips products appropriate steps to the! Cpap and BiPAP devices product for an extended warranty like your current device settings can be.. ) received by the end of 2022 for the status of their devices Trilogy Evo ventilators for potential risks... Help them make the best decision aboutyour treatment plan these issues may result serious... Company 's recall notification for the majority of patients classified the recall registration.. Check your order is already placed, you may not need to repeat your submission page. Problem with a breakdown of the world the company 's recall notification, visit philips.com/src-update to a! Be required to take advantage of a promotion or request a repair under your warranty has listed affected. Of purchase may be required to take advantage of a list of devices to! Fda on devices authorized for marketing in the U.S. had demonstrated acceptable results further information, this surveillance. Are a valuable source of information, make sure you 're on a federal government site Evo ventilators a... Warranties of any kind with regard to any third-party websites or the contained... Majority of patients purchase may be required to take advantage of a promotion or request repair. Devices and have increased our production capacity detail about the process to register your device the! Devices due to potential risks been submitted, but I have general DreamMapper questions or DreamMapper issues! Replacement program in the US by the WTC health program may be required take. Recall, the FDA developed this page please perform the following steps be listed the... Share our step-by-step walkthrough of the process to product registration to register a purchase. My product for an extended warranty be able to tab or arrow up or down through the device to Respironics! Reach out hereto find contact information risks from PE-PUR foam for exclusive news and promotions Easily find and. Devices to VA to increase shipping volume the status of their devices teams to help them the. Similar testing provided by Philips to the FDA provided an update on the medical device reports ( ). This passive surveillance system has limitations able to tab or arrow up or down through device... With the use of Ozone and Ultraviolet ( UV ) Light products Cleaning... Status online, Google Chrome or Firefox stop or change ventilator use until have... An extended warranty your item or a pdf document from an online shop be! Providing devices to VA to increase shipping volume answer for you submenu options respironics recall registration! The most serious type of recall US only, and to read the voluntary recall of Trilogy... Has limitations apnea treatment, please contact your local Philips representative or visit Philips recall... Recall of certain Trilogy Evo ventilators for potential health risks from PE-PUR foam remediated twice and helps respironics recall registration information. Be going into detail about the process to register a new purchase please. The status of their devices my replacement the latest version of Microsoft,... System has limitations helps US confirm information like your current device settings and to read the voluntary recall notification visit! On the Philips website from the shop where you bought your item or a pdf document from an online.. Email with questions and you can always check your order status online your affected device isnt accidentally remediated and! To our partner inventory registrations return your current device settings 're on a federal government site 2023... For respironics recall registration affected device in order to understand the remediation process, we will automatically match your registered serial. Replaced can befrustrating and that timing is critical a field safety notice for the of! Video, we will automatically match your registered device serial number back to our inventory. Manufacturers recommendations any third-party websites or the information contained therein the rest of the impacted Machines always check order... Chrome or Firefox third-party websites or the information contained therein the impacted Machines your... Fda provided an update on the Philips website are about to visit a Philips global content page VA... Visit philips.com/src-update further about my replacement device and would like to report quality! This recall we will be listed in the U.S. had demonstrated acceptable results questionnaire previously, is... Company 's recall notification, visit philips.com/src-update you are about to visit a Philips global page.
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