We are providing agencies with required information related to the initial launch and ongoing implementation of the projected correction. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. We are treating this matter with the highest possible seriousness, and are working to address this issue as efficiently and thoroughly as possible. Please be assured that our teams are working on a comprehensive correction program to support patients with an affected device. The letter offered the following recommendations. At this time, affected devices are on manufacturing and ship hold. We thank you for your patience as we work to restore your trust. Have regulatory authorities classified the severity of the recall? [2] Cancer risk in adherent users of polyurethane foam-containing CPAP devices for sleep apnoea, European Respiratory Journal 2022, in press (https://doi.org/10.1183/13993003.00551-2022), Grgoire Justeau, Chlo Gervs-Pinqui, Marie Jouvenot, Thierry Pigeanne, Sandrine Launois, Laurene Leclair-Visonneau, Philippe Masson, Acya Bizieux-Thaminy, Sbastien Bailly, Nicole Meslier, Abdelkebir Sabil, Jean-Louis Racineux, Wojciech Trzepizur, and Frdric Gagnadoux. Philips CPAPs cannot be replaced during ship hold. 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. 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. For more information click here. What devices have you already begun to repair/replace? Please note that some people will also receive a copy of the Notice by email or post. See Ventilator Alarms on pages 2 4 of your Trilogy 100 Instructions for Use. Additionally, the device Instructions for Use provide product identification information to assist with this activity. This led to approximately 99,000 MDRs filed by Philips Respironics to the FDA from April 2021 through December 31, 2022. People who receive breathing support from the affected Philips BiPAP (ventilator) machines. VA has distributed approximately 300,000 Philips CPAP or BiLevel PAP devices for Veteran . 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. 4. Philips Australia expects to have completed the replacement program by the end of 2022 for the majority of devices where, by 12 December 2022, patients (1) registered a device type listed below; and (2) provided their device settings preference to Philips. Do affected units exhibit features that customers / users should watch out for? 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. In these situations, and at the discretion of the treating clinical team, the benefit of continued usage of these ventilator devices may outweigh the risks. As part of the notification process, customers and patients will be provided with more information on the next steps to implement the solution as it becomes available. Philips CPAP Recall Information. Philips Sleep and respiratory care. Consult your Instructions for Use for guidance on installation. Product testing has demonstrated that off-gassing mostly occurs during initial operation and may possibly continue throughout the devices useful life. The recall notification(U.S. only) / field safety notice (International Markets) informs customers and users of potential impacts on patient health and clinical use related to this issue. On Friday July 2 2021, following consultation with the Therapeutic Goods Administration (TGA) and Medsafe, Philips Australia and New Zealand announced it is conducting an Urgent Product Defect Correction in Australia and Recall for Product Correction in New Zealand for the specific affected devices. As a first step, if your device is affected, please start theregistration process here. Our goods and services come with guarantees that cannot be excluded under the Australian and New Zealand Consumer Law. Philips will provide further information regarding warranty replacement procedures during this issue when it is available. Philips Respironics initiated a voluntary recall notification/field safety notice* to address potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in specific CPAP, BiPAP and mechanical ventilator devices. Philips has been in full compliance with relevant standards upon product commercialization. CHEST MEMBERSHIP About Membership . To resolve this situation as quickly as we can, we are doing the following: Patients who are concerned should check to see if their device is affected by the corrective action. This factor does not refer to heat and humidity generated by the device for patient use. The products were designed according to, and in compliance with, appropriate standards upon release. This effort includes wide-scale, global ramping up of manufacturing, repair, services, supply chain and other functions to support the correction. https://doi.org/10.1183/13993003.00551-2022, Continued patient outreach through mailing, call center, websites and direct contact with interest groups, Met the requirements in FDA's 518(a) order and continue to report progress, Around 5.5M devices expected to berepaired or replaced, Equivalent to over 5x previous annualproduction volume, >1 thousand new product configurationsreleased globally, Partnering with DMEs for patientdelivery, Quadrupledproduction capacity compared to pre-recall, >1,000people cross functional team engaged, Dependencyon supply of materials and global logistics capacity, ~90% production and 80% shipment of recall units in 2022, Lowprevalence of significant visible foam degradation, Evenwhen significant visible particulates are formed, likely to accumulate insidethe device, Finalizetoxicological risk assessment of the VOC emissions resulting from ozone-inducedfoam degradation in DreamStation1 devices Expected in Q2 2023, Completetesting for SystemOne(~26% of registered devices) and DreamStationGo (~1%), which contain the exact same foam as the DreamStation1 devices Expected in Q2 2023, CompleteVOC and PM testing, as well as chemical evaluation and toxicologicalassessments for Trilogy 100/200 (~3%) and OmniLab(~2%), where a different PE-PUR foam is used Expected in Q3 2023, Ongoingengagement with FDA and other competent authorities, There were thirteen identified epidemiological studies, all of which found no consistent statistical association between use of PAP devices - including Philips Respironics- and the risk of cancer in patients with obstructive sleep apnea (OSA) - click, Eleven studies provided limited additional insights, but their results also suggested no excess risk of cancer associated with use of PAP devices, The 2022 study by Palm and others reported more frequent prescription of respiratory relief medication among patients with both OSA and obstructive lung disease, but no statistical difference in hospitalization, i.e. Create account Create an account Theremediation of this field safety notice is underway and has started for the following devices: DreamStationCPAPs DreamStationBiPAPs DreamStationST/AVAPS 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. As a result of extensive ongoing review, on June 14, 2021, Philips voluntarily decided to issue a global recall notification related to sound abatement foam used in specific Philips Continuous Positive Airway Pressure (CPAP), BiLevel Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators. The recall notification(U.S. only) / field safety notice (International Markets) informs customers and users of potential impacts on patient health and clinical use related to this issue. A-Series BiPAP A30 (Ventilator) and A-Series BiPAP A40 (Ventilator). The correction program is now in progress for the following devices: DreamStation CPAP, Auto CPAP and Auto BiPAP DreamStation ASV DreamStation AVAPS System One CPAP, CPAP Auto and BiPAP Auto (50 and 60 Series) System One ASV4 (50 and 60 Series) C Series S/T and AVAPS A-SeriesBiPAP (A40 and A30) DreamStation Go With regard to mechanical ventilators, Philips is deploying a corrective action to address the issues described in the correction notification. Customers, patients, users and clinicians are instructed to follow the guidance contained in the recall notification (U.S. only) / field safety notice (International Markets). 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. You can access the Philips RS North America webpage by clicking here. 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). 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. Testing is ongoing and you can obtain further information about the testing and matters relating to the recall from the device manufacturer, Philips RS North America LLC. High heat and high humidity environments may also contribute to foam degradation in certain regions. To register your device and check if your machine is included in the recall: Locate the serial number of your device. Are you still taking new orders for affected products? Always ensure you are being taken care of, i.e. 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). Also known as BiPAP A40 Ventilator (A-Series) (not marketed in US), Also known as BiPAP A30 Ventilator (A-Series) (not marketed in US). However, while standards have been updated, products developed on the prior standard are still in compliance with medical device regulations. Philips Respironics (Philips) voluntarily recalled certain ventilators, bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway. The site is secure. Selected products Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. 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. For more information click here. Discuss with patient (or their caregiver, as appropriate) whether care and treatment plan should change as a result of this recall. Also known as BiPAP A40 Ventilator (A-Series), Also known as BiPAP A30 Ventilator (A-Series). Patient safety is our top priority, and we are committed to supporting our . 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. Respond immediately, as a High Priority alarm alerts you to critical issues with your breathing or the ventilators operation. The company will replace the current sound abatement foam with a new material that is not affected by this issue, and has already begun this process. You are about to visit the Philips USA website. Begin registration process 877-907-7508 News and Updates > Important update to Philips US recall notification Important update to Philips US recall notification November 16, 2021 Philips has updated the US recall notification to align with the FDA's recommendation in connection with these recalls and provide broader guidance on use. This recall notification / field safety notice has not yet been classified by regulatory agencies. See all support information To date there have been no reports of death from exposure to the recalled devices. The website provides current information on the status of therecall notification (U.S. only) / field safety notice (International Markets) and how to receive permanent corrective action to address the two issues. Doing this could affect the prescribed therapy. 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. All Affected Devices Manufactured Before 26 April 2021, All Device Serial Numbers. This includes Dreamstation, Dreamstation Go, Dreamstation ASV/ST/AVAPS, System One, and Remstar SE Auto CPAP unit. 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. With regard to mechanical ventilators, Philips is deploying a corrective action to address the issues described in the correction notification. 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. How long will it take to address all affected devices? Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. Affected devices may be repaired under warranty. Contact your clinical care team to determine if a loan device is required. These devices are prescribed for people with obstructive sleep apnea syndrome to keep their airways open during sleep, for those who have respiratory insufficiency (not enough oxygen breathed in or carbon dioxide breathed out), or respiratory failure (stop breathing). When will the correction for this issue begin? For more information on the recall notification, as well as instructions for customers, users and physicians, affected parties may contact their local Philips representative or visit www.philips.com/SRC-update. health outcomes, was observed for OLD among OSA patients between the users or polyurethane PAP and non-foam PAP - click here for more details. For more information on the recall notification for customers, users and physicians, please click here. Follow our step-by-step guide here, which includes details for return of old devices in Australia and New Zealand. 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. Make an appointment with your physician to discuss whether it is safe to stop therapy or an alternative ventilator option is required. If you have a secondary back up device, switch over to that device. 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. Are affected devices being replaced and/or repaired? Philips Respironics Product Recall: Important Information for AvantSleep Clients. Updating everyone on what they need to know and do, and to participate in the corrective action. If you are a patient who has been affected by this correction, please do not try to remove the foam from your device. Medical Device Recalls, Recalls, Market Withdrawals and Safety Alerts, Philips Respironics Recalls Certain BiPAP Machines for Plastic Issue that May Expose Patients to Certain Chemicals of Concern, Update: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication, was corrected or replaced through the June 2021 recall, Certain Philips Respironics BiPAP Machines Recalled Due to a Plastic Issue, Certain Philips Respironics BiPAP Machines Recalled Due to a Plastic Issue: FDA Safety Communication, FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls, report adverse reactions or quality problems, Product Name: Philips Respironics BiPAP A30, A40, V30, and OmniLab Advanced+. 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. A-Series BiPAP V30 (Auto Ventilator) and OmniLab Advanced+ machines are used in clinical environments only. 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. High heat and high humidity environments may also contribute to foam degradation in certain regions. 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. 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. Updating everyone on what they need to know and do, and to participate in the corrective action. For example, spare parts that include the sound abatement foam that is the subject of the corrective action are on hold. We have established a claims processing and support center to assist you. Register affected devices on the recall notification (U.S. only) / field safety notice (International Markets), www.philips.com/SRC-update. The following products listed are affected by the correction: Continuous Ventilator, Minimum Ventilatory Support, Facility Use, Information for Trilogy 100 patients with a repaired device. If your ventilator is alarming with a High Priority alarm, you must do the following: 1. Philips Australia will work with your clinical care team to arrange a loan device, where required. Philips Respironics continues to engage with the US Food and Drug Administration (FDA)on the steps it has taken in response to the FDAs Form 483 observations Since July 2022, Philips Respironics has been in discussions with the US Department of Justice (DOJ), acting on behalf of the FDA, regarding the terms of a proposed consent decree to address the identified issueson a forward-going basis In addition, on April 8, 2022, Philips Respironics and certain of Philips subsidiaries in the US received a subpoena from the DOJ to provide information related to events leading to the Philips Respironics recall. We are treating this matter with the highest possible seriousness, and are working to address this issue as efficiently and thoroughly as possible. (0044) 20 8089 3822 Physicians and other medical care providers Philips Australia will work with your clinical care team to arrange a loan device, where required. In certain regions to address this issue when it is safe to stop therapy an! 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