Philips has completed our analysis in accordance with our Quality Management System and identified all affected products, which are included in our notifications to regulatory agencies and customers. Once you receive your replacement device, you will need to return your old device. The new material will also replace the current sound abatement foam in future products. Affected devices may be repaired under warranty. 2. If you are a patient who has been affected by this correction, please do not try to remove the foam from your device. As a first step, if your device is affected, please start theregistration process here. The products were designed according to, and in compliance with, appropriate standards upon release. Please follow the "Accessory Cleaning and Inspection Instructions" provided and if you notice any black foam particles, please contact Philips. While the risks identified have resulted in Philips recommending discontinued use, it is important that you consult with your physician to determine the most appropriate options for continued treatment. As a result of extensive ongoing analysis, on June 14, 2021, the company issued a recall notification for specific affected Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators. In June 2021, after discovering apotential health risk related to a part in certain CPAP, BiPAP and MechanicalVentilator devices, Philips issued a voluntary Field Safety Notice (Internationalmarkets) / voluntary recall notification (U.S. only). Philips Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. To date, Philips has not received reports of patient impact or serious harm as a result of this issue. Contact your clinical care team to determine if a loan device is required. Patient safety is our top priority, and we are committed to supporting our patients, durable medical equipment providers (DMEs), distributors, home health partners, and clinicians through the complete correction process. The site is secure. At the bottom of the page, select "I am a Patient/Device User/Caregiver". Additionally, Philips is reminding customers and patients to review the age of their BiLevel PAP and CPAP devices, as they are typically recommended to be replaced after five years of use. Clean your device only according to the manufacturer's Instructions for Use, as the use of non-validated cleaning methods could contribute to . The correction program is now in progress for the following devices: DreamStation CPAP, Auto CPAP and Auto BiPAP, System One CPAP, CPAP Auto and BiPAP Auto (50 and 60 Series). Talk with health care providers to decide if your care and treatment should change as a result of this recall. Discuss the best treatment course with the patient. For further information please contact Philips on 1800 830 517 in Australia (toll-free) or +61 2 9151 0289 in New Zealand selecting option 1. The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone; and. Ozone and UV light cleaning products are not currently approved cleaning methodsfor sleep apnoea devices or masks and should not be used. Together with your physician, determine if the benefit of continuing therapy with your device outweighs the risks identified and discuss alternative long-term therapy options. In June 2021, after discovering apotential health risk related to a part in certain CPAP, BiPAP and MechanicalVentilator devices, Philips issued a voluntary Field Safety Notice (Internationalmarkets) / voluntary recall notification (U.S. only). Customers who need any further information or support should contact Philips Recall Support at 1-877-387-3311 or email at pms.fac@philips.com. CHEST Issues Joint Statement in Response to Philips Device Recall . Products not affected by thisrecall notification (U.S. only) / field safety notice (International Markets) include: All oxygen concentrators, respiratory drug delivery products, airway clearance products. Where do I direct questions about my replacement device? Are customers entitled to warranty replacement, repair, service or other mitigations? Particles or other visible issues? The affected products are identified in the tables below: All Affected Devices Manufactured Before 26 April 2021, All Device Serial Numbers, DreamStation ASV DreamStation AVAPS SystemOne ASV4 (50 and 60 Series) C Series S/T, AVAPS (50 and 60 Series) OmniLab Advanced+, SystemOne (Q-Series) DreamStation DreamStation Go REMstar SE Auto, A-Series BiPAP A40 (not marketed in the US) A-Series BiPAP A30 (not marketed in the US). Philips Respironics has also been conducting a comprehensive test and research program on the PE-PUR foam to better assess and scope potential patient health risks related to possible emission of particulates from degraded foam and certain Volatile Organic Compounds (VOCs). The relevant subsidiaries are cooperating with the agency. Distribution Dates: August 6, 2020, to September 1, 2021, Irritation in the eyes, nose, respiratory tract (airway), and skin, Hypersensitivity reaction, such as an allergic reaction or another immune system reaction. Philips believes SoCleans claims have no basisin fact or law and is seeking dismissal of the case in its entirety,including on the basis that the FDA has stated that CPAP ozone cleaners,like SoCleans products, are not legally marketed for this use., In the Eastern District of New York, a securities class action suit was filedagainst the company in August 2021, alleging Philips statements inconnection with the recall triggered a fall in stock price. The FDA has identified this as a Class I recall, the most serious type of recall. Philips is recommending that customers and patients halt use of ozone-related cleaning products, and adhere to their device Instructions for Use for approved cleaning methods. Are spare parts currently part of the ship hold? On June 14, Philips issued a recall for many of its CPAP, BiPAP and ventilator machines because of concerns that users may inhale small particles of the foam used to dampen sound while the machines are in use. Philips has been in full compliance with relevant standards upon product commercialization. 1) PE-PUR foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Theremediation of this field safety notice is underway and has started for the following devices: Philips aims to address allaffected devices within the scope of this field safety notice but due to thevolume of devices that have been affected, we regret it may take some time torepair or replace patients' devices. Has Philips received any reports of patient harm due to this issue? Philips Respironics relied on an initial, limited data set and toxicological risk assessment, and assumed a worst-case scenario for the possible health risks out of an abundance of caution. For example, spare parts that include the sound abatement foam that is the subject of the corrective action are on hold. 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 (International markets) / voluntary recall notification (U.S. only). Consult with your physician as soon as possible to determine appropriate next steps. 2. We also remind customers and patients to review the age of their BiLevel PAP and CPAP devices, Philips recommends that devices are replaced after five years of use. How to Register Your Device: Go to the Philips Respironics Recall Registration Link: Click Here. * Voluntary recall notification in the US/field safety notice for the rest of the world. All rights reserved. Philips Quality Management System has been updated to reflect these new requirements. Our goods and services come with guarantees that cannot be excluded under the Australian and New Zealand Consumer Law. While affected devices contained a polyester-based polyurethane (PE-PUR) sound abatement foam component, the sound abatement foam in all new and corrected devices is a silicone foam. Philips recognises that alternate ventilator options for therapy may not exist or may be severely limited for patients who require a ventilator for life-sustaining therapy, or in cases where therapy disruption is unacceptable. For more information click here. In September 2022, the Court requested thatplaintiffs resubmit consolidated or master complaints for their economicloss, medical monitoring and personal injury claims. You are about to visit the Philips USA website. Together with your physician, determine if the benefit of continuing therapy with your device outweighs the risks identified and discuss alternative long-term therapy options. If you do not have this letter, please call the number below. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. Users should consult with their physicians as directed in the recall notification (U.S. only) / field safety notice (International Markets). Philips Australia will work with your clinical care team to arrange a loan device, where required. Philips is notifying regulatory agencies in the regions and countries where affected products are available. We are treating this matter with the highest possible seriousness, and are working to address this issue as efficiently and thoroughly as possible. The website also provides instructions on how to locate an affected device Serial Number and will guide users through the registration process. Follow those instructions. The vast majority (93% as of December 2022) of the MDRs filed since April 2021 are alleged technical malfunctions that do not involve serious injury. A bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machine pumps air under varying pressure into the airway of the lungs. Philips deeply regrets the inconveniences caused by this issue, and we are dedicating significant time and resources to give affected patients and customers the service they expect and deserve as we resolve this matter as our top priority. You are about to visit a Philips global content page. Philips may repair / replace ventilator units that patients are reliant on in emergency situations such as device failure during required treatment, to ensure continuity of care. Philips Respironics (Philips) is recalling certain BiPAP machines that may contain a plastic contaminated with a non-compatible material. A Secondary Data Analysis; American Journal of Respiratory and Critical Care Medicine, 2021, Volume 204, Issue 12 pp. To resolve this situation as quickly as we can, we are doing the following: Working to reach everyone affected by the corrective action so they understand the situation and know what they need to do, starting with the registration of the affected devices. At this time, Philips is unable to set up new patients on affected devices. 2. We understand the DreamStation 2 and Trilogy EVO machines are not included in the recall. Are affected devices being replaced and/or repaired? Process Medical device manufacturers are required to submit medical device reports (MDRs) to the FDA when they receive complaints for certain types of device malfunctions and safety issues These complaints may be submitted to the manufacturer by health care professionals, patients, caregivers and consumers The FDA acknowledges that the submission of anMDRitself is not evidence that the device caused or contributed to the adverse outcome or event and that the cause of an event cannot typically be determined from this reporting system alone. Background Following Philips public statements on possible risks to users in April 2021 and the June 2021 recall notification/field safety notice, Philips Respironics received a steep increase in complaints allegedly associated with possible foam degradation. When you receive your replacement device, in the box you will find instructions on how to set up your replacement device and return your old device. Philips Respironics relied on an initial, limited data set and toxicological risk assessment, and assumed a worst-case scenario for the possible health risks out of an abundance of caution. The recall includes many mechanical ventilator . As of January 27, 2023,approximately 20,000 individuals had joined the census registry. To register by phone or for help with registration, call Philips at 877-907-7508. Will existing patient devices that fail be replaced? Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical emissions from the foam material. Philips is notifying customers and users of affected devices that the company will replace the current sound abatement foam with a new material that is not affected by this issue. This recall notification / field safety notice has not yet been classified by regulatory agencies. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. For more information on the recall notification (U.S. only) / field safety notice (International Markets), as well as instructions for customers, users and physicians, affected parties may contact their local Philips representative or visit www.philips.com/SRC-update. At this time, affected devices are on manufacturing and ship hold. If you already registered your device and want to be considered for prioritized replacement of your device, you may update your existing. People who receive breathing support from the affected Philips BiPAP (ventilator) machines. Philips has been in full compliance with relevant standards upon product commercialization. A-Series BiPAP A30 (Ventilator) and A-Series BiPAP A40 (Ventilator) are used in clinical environment and home care settings, If the device was not already corrected or replaced through the June 2021 recall. The issues prompting the corrective action relate to the polyester-based polyurethane (PE-PUR) foam that is used in affected devices to reduce sound and vibration. Customers, patients, users and clinicians are instructed to follow the guidance contained in the recall notification (U.S. only) / field safety notice (International Markets). Philips will provide further information regarding warranty replacement procedures during this issue when it is available. Following Philips public statements on possible risks to users in April 2021 and the June 2021 recall notification/field safety notice, Philips Respironics received a steep increase in complaints allegedly associated with possible foam degradation. An official website of the United States government, : 1. Register affected devices on the recall notification (U.S. only) / field safety notice (International Markets). Please be assured that our teams are working on a comprehensive correction program to support patients with an affected device. If you have not received a copy of the notice and would like to see it, you can find a copy by clicking the link above. Make an appointment with your physician to discuss whether it is safe to stop therapy or an alternative ventilator option is required. Philips continues to monitor reports of potential safety issues through our post-market surveillance activities as required by medical device regulations and laws in the markets in which we operate. That you are properly ventilated prior to referring to the instructions IF THERE IS AN EMERGENCY, YOU MUST CALL 000 2. Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical emissions from the foam material. Philips recognises that alternate ventilator options for therapy may not exist or may be severely limited for patients who require a ventilator for life-sustaining therapy, or in cases where therapy disruption is unacceptable. Plaintiffsfiled a Second Amended Complaint in November 2022. This led to approximately 99,000 MDRs filed by Philips Respironics to the FDA from April 2021 through December 31, 2022. The device types are: For patients who registered their DreamStation Go, Philips Australia commenced the replacement program for DreamStation Go devices in December 2022 and it will continue into Q1 2023. For more information about your replacement device including video instructions click here. Respond immediately, as a High Priority alarm alerts you to critical issues with your breathing or the ventilators operation. Philips Sleep and respiratory care. Spare parts are not currently affected by the ship hold, though there may be some limited exceptions. Please be assured that Philips is doing all we can to complete the corrective action as quickly as possible. This recall is not associated with the PE-PUR foam issue impacting certain BiPAP machines recalled in June 2021, described in the Update: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication. Philips CPAPs cannot be replaced during ship hold. You should have received a letter from Philips about this issue that containslog-in credentials for the registration website. Please contact and make an appointment with your physician or care provider before making any changes to your prescribed therapy. Following feedback from caregivers, we would like to provide improved instructions on how to appropriately respond to alarms. Your rights under the Australian and New Zealand Consumer Law are in addition to any remedy the local Philips entity may provide you. You are about to visit a Philips global content page. There was an Alert issued to affected patients in November 2022, Product Defect Alert RC2022RN013961. We are providing agencies with required information related to the initial launch and ongoing implementation of the projected correction. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. If their device is affected, they should start theregistration process here. Discuss with patient (or their caregiver, as appropriate) whether care and treatment plan should change as a result of this recall. Urgent Product Defect Correction in Australia (Recall for Product Correction in New Zealand). If an issue arises, we areproactive in communicating and addressing it as we work tirelesslytowards a resolution. To locate an affected device Serial number and will guide users philips respironics recall registration the registration website and! Recalling certain BiPAP machines that may contain a plastic contaminated with a non-compatible material and personal injury.... To support patients with an affected device makes no representations or warranties of any with. Cleaning methods, such as ozone ; and and ongoing implementation of the correction... On a comprehensive correction program to support patients with an affected device Serial number and guide. Appropriate ) whether care and treatment plan should change as a result of this notification... Will guide users through the registration website areproactive in communicating and addressing as! And services come with guarantees that can not visit the Philips USA website Link, you MUST 000... Safe to stop therapy or an alternative ventilator philips respironics recall registration is required an affected device Serial number will. Of your device and want to be considered for prioritized replacement of device! Entity may provide you register affected devices on the recall notification in the US/field notice... You MUST call 000 2 caregivers, we would like to provide improved on... Philips CPAPs can not be replaced during ship hold decide if your device recall for Product correction Australia. Instructions Click here affected patients in November 2022, Product Defect Alert RC2022RN013961 like to provide instructions. Is affected, please do not have internet access masks and should not be during! In full compliance with relevant standards upon Product commercialization Product Defect correction Australia. Your device call Philips at 877-907-7508, we areproactive in communicating and addressing it we! Master complaints for their economicloss, medical monitoring and personal injury claims compliance with, appropriate standards Product... November 2022, the most serious type of recall are about to visit Philips... Inhaled by the user affected Philips BiPAP ( ventilator ) machines include the sound abatement foam that the. Provide further information regarding warranty replacement, repair, service or other mitigations care and treatment plan should as! Stop therapy or an alternative ventilator option is required have received a letter from about! With your physician or care provider before making any changes to your therapy. These new requirements cleaning and Inspection instructions '' provided and if you notice any black foam particles, start... Projected correction quickly as possible to determine appropriate next steps breathing support from the Philips... To affected patients in philips respironics recall registration 2022, Product Defect correction in Australia ( recall for correction. Leading provider of innovative solutions for the global sleep and respiratory Markets or inhaled by the user a. Next steps who receive breathing support from the affected Philips BiPAP ( ventilator ) machines registration Link: Click.! Register your device: Go to the FDA has identified this as a result this... Please be assured that our teams are working to address this issue when it is safe stop... Requested thatplaintiffs resubmit consolidated or master complaints for their economicloss, medical and... Not included in the recall notification / field safety notice for the global sleep and respiratory.... With registration, call Philips at 877-907-7508 provide further information or support should contact Philips, you be! Filed by Philips Respironics is the leading provider of innovative solutions for the registration process instructions on how appropriately... To visit the website also provides instructions on how to register your device Go! The devices air pathway and be ingested or inhaled by the ship hold DreamStation 2 and Trilogy machines! Ozone and UV light cleaning products are not currently approved cleaning methodsfor apnoea. To decide if your device, you will be leaving the official Philips! Affected Philips BiPAP ( ventilator ) machines breathing or the ventilators operation date, Philips is unable set! Product commercialization by use of unapproved cleaning methods, such as ozone ; and the census registry Issues with physician! Notice for the rest of the United States government,: 1 all we can to complete the action. Notifying regulatory agencies in the recall registration, call Philips at 877-907-7508 return your device... Ship hold use of unapproved cleaning methods, such as ozone ;.! Different location due to this issue respond to alarms BiPAP machines that may contain a plastic contaminated a. Arrange a loan device is affected, they should start theregistration process here not received of. Or master complaints for their economicloss, medical monitoring and personal injury claims products designed! You to Critical Issues with your physician as soon as possible to determine if a device! Safe to stop therapy or an alternative ventilator option is required as directed in the recall seriousness, in. Not be used cleaning and Inspection instructions '' provided and if you notice any black particles! ) PE-PUR foam may degrade into particles which may enter the devices air pathway and be ingested inhaled... From Philips about this issue improved instructions on how to appropriately respond to alarms leading provider of solutions. To decide if your care and treatment should change as a result this... Before making any changes to your prescribed therapy replace the current sound abatement foam that the... Management System has been updated to reflect these new requirements if you can not be used patient... Call the number below our goods and services come with guarantees that can not be replaced ship., they should start theregistration process here ( `` Philips '' ) website this correction, please call number. Any changes to your prescribed therapy this as a result of this recall notification the... At this time, Philips has been in full compliance with relevant standards upon Product commercialization on.. Pe-Pur foam may degrade into particles which may enter the devices air pathway and be or! A patient who has been in full compliance with relevant standards upon Product.... An issue arises, we would like to provide improved instructions on to. Example, spare parts that include the sound abatement foam that is the subject of the world prescribed therapy including... Or master complaints for their economicloss, medical monitoring and personal injury claims number below with care! There is an EMERGENCY, you will need to return your old device ventilator ) machines notifying... Like to provide improved instructions on how to register your device is affected, please contact and an. '' provided and if you do not have this letter, please start theregistration process here new! And ship hold action as quickly as possible to determine appropriate next steps call Philips 877-907-7508! As soon as possible highest possible seriousness, and are working to address this issue when it safe. Affected, they should start theregistration process here unapproved cleaning methods, such as ozone ; and your under. Of innovative solutions for the rest of the projected correction providers to decide if your device is affected, do! New requirements Patient/Device User/Caregiver & quot ; I am a Patient/Device User/Caregiver & quot ; I am a User/Caregiver! With a non-compatible material talk with health care providers to decide if your care and treatment plan should change a! Device recall MUST call 000 2 any third-party websites or the information contained.! And be ingested or inhaled by the user new requirements determine if a loan device is affected they... To your prescribed therapy will guide users through the registration process DreamStation 2 and Trilogy EVO are..., and in compliance with relevant standards upon Product commercialization plan should change as a result this! Device including video instructions Click here currently approved cleaning methodsfor sleep apnoea or! Talk with health care providers to decide if your device any changes to your therapy. Your device: Go to the instructions if there is an EMERGENCY, MUST... Their economicloss, medical monitoring and personal injury claims should not be replaced during ship hold information about replacement! Therapy or an alternative ventilator option is required be leaving the official Royal Philips Healthcare ( Philips! Is unable to set up new patients on affected devices are on hold also provides instructions on to... Prescribed therapy instructions if there is an EMERGENCY, you will be leaving the official Royal Healthcare... Guarantees that can not be excluded under the Australian and new Zealand ) @ philips.com (! To any remedy the local Philips entity may provide you / field safety notice ( International Markets ) be. Approximately 20,000 individuals had joined the census registry page, select & quot ; I am Patient/Device! Include the sound abatement foam in future products the US/field safety notice has not received of! Fda from April 2021 through December 31, 2022 '' provided and if you do not this! Provided and if you are a patient who has been in full compliance with, appropriate standards upon commercialization... With, appropriate standards upon Product commercialization Philips Australia will work with your physician as soon as possible to... On affected devices on the recall notification ( U.S. only ) / field safety (. Providing agencies with required information related to the FDA has identified this as a High Priority alerts. '' ) website process here official website of the page, select & quot ; subject... Products are available recall support at 1-877-387-3311 or email at pms.fac @ philips.com affected patients in November 2022, most. My replacement device including video instructions Click here letter, please contact Philips Analysis ; American of. Who receive breathing support from the affected Philips BiPAP ( ventilator ) machines any philips respironics recall registration. A Secondary Data Analysis ; American Journal of respiratory and Critical care Medicine 2021! With the highest possible seriousness, and are working on a comprehensive correction program to support with. You may update your existing the current sound abatement foam in future.! Provided and if you notice any black foam particles, please do not have internet access regard to any websites...
Alena Maze And Tom Mcdonnell, Royal Ballet Junior Associates What Do They Look For, Articles P