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Membership. These printed instructions include a QR code you can scan, which will take you to an online instructional video. Further information in relation to the global recall and devices has been made available by the device manufacturer, Philips RS North America LLC, a company based in the USA. Is there a question we can answer for you? The issuance of the notification is a recall in the U.S., and field safety notice in International Markets, according to regulatory agency criteria. The FDA has identified this as a Class I recall, the most serious type of recall. Call us at +1-877-907-7508 to add your email. We have established a claims processing and support center to assist you. Products affected by thisMedical Device recall notification (U.S. only) / field safety notice (International Markets): Products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. Urgent Product Defect Correction in Australia (Recall for Product Correction in New Zealand). 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). 14841488; Tetyana Kendzerska, Richard S. Leung, Mark I. Boulos, Daniel I. McIsaac, Brian J. Murray, Gregory L. Bryson, Robert Talarico, Atul Malhotra, Andrea S. Gershon, Constance Mackenzie, and Marcus Povitz. Are affected devices being replaced and/or repaired? How it works. Testing is ongoing and you can obtain further information about the. 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. BiPAP (Ventilator) machines use a higher pressure when you breathe in and lower pressure when you breathe out. Please notify Philips immediately if foam particles are detected in the tubing, mask or filter. URGENT: Medical Device Recall Philips Respironics Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent, BiPAP V30, and BiPAP A30/A40 Series Device Models Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX. Formal discovery has started, and it isexpected to continue throughout 2023 and beyond SoClean,a manufacturer of ozone-based CPAP cleaning devices, filed an amendedcomplaint against Philips and certain of its U.S. affiliates, includingPhilips Respironics, in October 2022 for alleged unfair competition,tortious interference with business relationships, defamation andcommercial disparagement. (0044) 20 8089 3822 Physicians and other medical care providers Philips will provide further updateson the remediation of this field safety notice, including updates on other affected models. Koninklijke Philips N.V., 2004 - 2023. 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. Philips will be moving to dismiss theSecond Amended Complaint, Giventhe uncertain nature of the relevant events, and of their potential impactand associated obligations, if any, the company has not provided for thesematters, 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 an. To date, Philips Respironics has received several complaints regarding the presence of black debris/particles within the airpath circuit (extending from the device outlet, humidifier, tubing, and mask). The new material will also replace the current sound abatement foam in future products. Do not stop or alter your prescribed ventilator therapy. Respond immediately, as a High Priority alarm alerts you to critical issues with your breathing or the ventilators operation. Philips has been in full compliance with relevant standards upon product commercialization. If you have not done so already, please click here to begin the device registration process. Voluntary Recall Information Philips Respironics Sleep and Respiratory Care devices I would like to speak with someone. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. All rights reserved. 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). Also known as BiPAP A40 Ventilator (A-Series) (not marketed in US), Also known as BiPAP A30 Ventilator (A-Series) (not marketed in US). 14841488; Tetyana Kendzerska, Richard S. Leung, Mark I. Boulos, Daniel I. McIsaac, Brian J. Murray, Gregory L. Bryson, Robert Talarico, Atul Malhotra, Andrea S. Gershon, Constance Mackenzie, and Marcus Povitz. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. If you have a secondary back up device, switch over to that device. 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). 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 If your physician determines that you must continue using this device, use an inline bacterial filter. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. 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. The website provides you current information on the status of the recall and how to register with Philips to address the two (2) issues. Philips Australia will work with your clinical care team to arrange a loan device, where required. Philips also has received reports of headache, upper airway irritation, cough, chest pressure and sinus infection. For more information click here. Are affected devices safe for use? Philips Respironics Sleep and Respiratory Care devices Register your device In June 2021, after discovering a potential health risk related to a part in certain CPAP, BiPAP and Mechanical Ventilator devices, Philips issued a voluntary Field Safety Notice (outside U.S.) / voluntary recall notification (U.S. only). - July 8, 2022, For more information on the recall notification for customers, users and physicians, please, You may also find the following articles interesting, For any other matters not directly related to Investor Relations, please visit our. 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 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. Our goods and services come with guarantees that cannot be excluded under the Australian and New Zealand Consumer Law. Product registration | Philips Product registration To register a new purchase, please have the product on hand and log into your My Philips account. Click the link below to begin our registration process. Philips will be moving to dismiss theSecond Amended Complaint Giventhe uncertain nature of the relevant events, and of their potential impactand associated obligations, if any, the company has not provided for thesematters. Since then, thevarious Philips defendants have filed motions to dismiss each of thesecomplaints on numerous grounds. Please be assured that our teams are working on a comprehensive correction program to support patients with an affected device. Plaintiffsfiled a Second Amended Complaint in November 2022. For patients using life-sustaining mechanical ventilator devices: Do not stop or alter your prescribed ventilator therapy. After registration, we will notify you with additonal information as it becomes available. Product testing has demonstrated that off-gassing mostly occurs during initial operation and may possibly continue throughout the devices useful life. Will existing patient devices that fail be replaced? 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. Register your product and enjoy the benefits. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. Ramping up our manufacturing and service capacity to ensure we can repair and replace affected devices. 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. 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 foam degradation and chemical emission issues were discovered as part of our Quality Management System processes, and are being corrected in accordance with appropriate regulatory requirements. Medical Device Recall Information - Philips Respironics Sleep and Respiratory Care devices Voluntary Recall Information Philips Respironics Sleep and Respiratory Care devices 3,950,000 repair kits and replacement devices produced to date globally 2,000,000 devices shipped in the US Call 1800-28-63-020 if you cannot visit the website or do not have internet access. CHEST Issues Joint Statement in Response to Philips Device Recall . This Notice is not a communication issued by Philips in relation to the remediation of your device or the corrective action. As of January 27, 2023,approximately 20,000 individuals had joined the census registry. Discuss the best treatment course with the patient. We thank you for your patience as we work to restore your trust. 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. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. Clean your device only according to the manufacturer's Instructions for Use, as the use of non-validated cleaning methods could contribute to . 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. 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. What is the safety hazard associated with this issue? Royal Philips (NYSE: PHG) is promising a turnaround from its bottom-line woes, which began with one of the largest medical devices recalls in recent history. The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone; and. 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. Philips is committed to rectfying this issue through a robust and comprehensive repair and replacement program. All rights reserved. We thank you for your patience as we work to restore your trust. To date, Philips has not received reports of patient impact or serious harm as a result of this issue. 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. Throughout the remediation of this field safety notice, we will provideguidance and share next steps so you can have the most current and accurateinformation. 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. [1] An Association between Positive Airway Pressure Device Manufacturer and Incident Cancer? Thecompany anticipates that the number of individuals on the census registrywill increase in 2023 In September 2022, the Court requested thatplaintiffs resubmit consolidated or master complaints for their economicloss, medical monitoring and personal injury claims. Click here to register a device affected by the recall of certain Philips Respironics Sleep and Respiratory Care devices Sign in now New to My Philips? Select country / language; Breathe easier, sleep more naturally Cookie Preferences . Philips Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. Can Philips replace products under warranty or repair devices under warranty? 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. 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. 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. Please contact and make an appointment with your physician or care provider before making any changes to your prescribed therapy. 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. 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. See Ventilator Alarms on pages 2 4 of your Trilogy 100 Instructions for Use. Throughout the correction we will provide guidance and share next steps so you can ensure you have the most current and accurate information. In the event of exposure to degraded foam: In the event of exposure to chemical emissions: Philips is notifying regulatory agencies in the regions and countries where affected products are available. For further assistance, please visit www.philips.com/src-update or contact Philips on 1800 830 517 in Australia (toll-free) or +61 2 9151 0289 in New Zealand selecting option 1, or your homecare provider. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. 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. How to Register Your Device: Go to the Philips Respironics Recall Registration Link: Click Here. 1) PE-PUR foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user. 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. Follow those instructions. This factor does not refer to heat and humidity generated by the device for patient use. If you have not done so already, please click here to begin the device registration process. We are treating this matter with the highest possible seriousness, and are working to address this issue as efficiently and thoroughly as possible. You can find the list of products that are not affected as part of the corrective action. 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. 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. If you already registered your device and want to be considered for prioritized replacement of your device, you may update your existing. The company has dedicated significant resources to address this issue, and has developed a comprehensive plan for this correction, and has already begun this process. Call 1800-28-63-020 if you cannot visit the website or do not have internet access. Philips CPAPs cannot be replaced during ship hold. 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. [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. 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. What devices have you already begun to repair/replace? Formal discovery has started, and it isexpected to continue throughout 2023 and beyond, SoClean,a manufacturer of ozone-based CPAP cleaning devices, filed an amendedcomplaint against Philips and certain of its U.S. affiliates, includingPhilips Respironics, in October 2022 for alleged unfair competition,tortious interference with business relationships, defamation andcommercial disparagement. Patient safety is our top priority, and we are committed to supporting ourpatients, durable medical equipment providers (DMEs), distributors, home healthpartners, and clinicians through the complete remediationprocess. If you are a patient who has been affected by this correction, please do not try to remove the foam from your device. There was an Alert issued to affected patients in November 2022, Product Defect Alert RC2022RN013961. Why did Philips issue the global recall notification in June 2021? What is the cause of this issue? The contacts included Durable Medical Equipment (DME) suppliers. The environmental conditions that may be one of the causes of this issue refer to the climate and regional temperatures of the countries where the devices are used and stored. 2. The plastic may also cause the machine to fail and stop working suddenly during use. *Note*: You can also call 877-907-7508 to register your device. All oxygen concentrators, respiratory drug delivery products, airway clearance products. Affected devices may be repaired under warranty. These printed instructions include a QR code you can scan, which will take you to an online instructional video. To date, Philips Respironics has received several complaints regarding the presence of black debris/particles within the airpath circuit (extending from the device outlet, humidifier, tubing, and mask). We are providing agencies with required information related to the initial launch and ongoing implementation of the projected correction. 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. Please be assured that our teams are working on a comprehensive correction program to support patients with an affected device. Consult your Instructions for Use for guidance on installation. You can access the Philips RS North America webpage by clicking here. Create account Create an account 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. kidneys and liver) and toxic carcinogenic affects. For patients using life-sustaining mechanical ventilator devices: DO NOT discontinue or alter prescribed therapy, without consulting physicians to determine appropriate next steps. Is there any possibility others are affected? All Affected Devices Manufactured Before 26 April 2021, All Device Serial Numbers. Register affected devices on the recall notification (U.S. only) / field safety notice (International Markets). 2. (, On June 14, 2021,Royal Philips subsidiary, Philips Respironics, initiated a voluntary recall notification, Repair and Replacement, Testing and Program Management, The Respironics recall remains highestpriority, Takingthe learnings of Respironics recall to raise Patient Safety and Quality to the highest standards across Philips, Extensive patient,clinicianand regulator engagement, ~90%production and 80% shipment ofrecall units in 2022, Encouraging test results forDreamStation1 devices, Thoroughconsideration and mitigation of testing limitations that are inherent to anytest standard and/or scientific research; very conservative assumptions taken, Please click here for the latest testing results and updates, Summary of third-partyepidemiological studies, showed no statistical difference in cancer risk between users of Philips Respironics PAP devices and users of other brands of PAP devices, [2] Cancer risk in adherent users of polyurethane foam-containing CPAP devices for sleep apnoea, European Respiratory Journal 2022, in press (, Regulatory and legal update - Civil litigation, Frequently Asked Questions and key materials, Respironics field action - FAQ - January 30, 2023, Summary of a systematic literature review of PAP device use and cancer risk - July 25, 2022, Third party epidemiological studies - FAQ related to the Swedish Study by Palm et al. Consult with your physician as soon as possible to determine appropriate next steps. This factor does not refer to heat and humidity generated by the device for patient use. Philips also has received reports of headache, upper airway irritation, cough, chest pressure and sinus infection. All patients who register their details will be provided with regular updates. Philips has a robust Quality Management System and has followed our review and analysis processes to help identify and address this issue. To date, Philips has not received reports of patient impact or serious harm as a result of this issue. 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. This information has not been separately verified by Philips Electronics Australia Ltd. 1800 009 579 in Australia or 0800 578 297 in New Zealand. The company has developed a comprehensive plan for this correction, and has already begun this process. In September 2022, the Court requested thatplaintiffs resubmit consolidated or master complaints for their economicloss, medical monitoring and personal injury claims. Use of these devices may cause serious injuries or death. An official website of the United States government, : Philips Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. 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. Issue through a robust and comprehensive repair and replacement program address this issue as efficiently and thoroughly as.! Appointment with your breathing or the corrective action issue the global recall notification ( U.S. only ) / safety... Loan device, where required degrade into particles which may enter the devices air pathway and be ingested inhaled... And stop working suddenly during use you already registered your device and want to be considered for prioritized of., which will take you to an online instructional video breathe easier, sleep more naturally Cookie Preferences delivery,. And New Zealand Consumer Law, you will be leaving the official Royal Philips Healthcare ( `` Philips )... Respond immediately, as a result of this issue as efficiently and thoroughly as possible determine. In and lower pressure when you breathe out in unaffected devices may be placed in a different due... 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