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. Philips Respironics recalled several models of DreamStation CPAP, BiLevel PAP, and mechanical ventilator machines and respirators on June 14, 2021. In the event of exposure to chemical emissions: The potential risks of exposure due to chemical emissions from affected foam include: headache/dizziness, irritation (eyes, nose, respiratory tract, skin), hypersensitivity, nausea/vomiting, toxic and carcinogenic effects. For more information click here. We are providing agencies with required information related to the initial launch and ongoing implementation of the projected correction. If your physician determines that you must continue using this device, use an inline bacterial filter. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. Particles or other visible issues? Our goods and services come with guarantees that cannot be excluded under the Australian and New Zealand Consumer Law. This Alert was related only to Trilogy 100 ventilators that were repaired. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design. Your rights under the Australian and New Zealand Consumer Law are in addition to any remedy the local Philips entity may provide you. Follow those instructions. We are providing agencies with required information related to the initial launch and ongoing implementation of the projected correction. 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. Click the link below to begin our registration process. 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. 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. Following consultation with the Therapeutic Goods Administration (TGA) and Medsafe, the Urgent Product Defect Correction in Australia and Recall for Product Correction in New Zealand will advise patients and customers to take the following actions: For patients using BiLevel PAP and CPAP devices: Stopping treatment suddenly could have an immediate and detrimental effect on patient health. Thecompany anticipates that the number of individuals on the census registrywill increase in 2023. 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. What is the cause of this issue? Your rights under the Australian and New Zealand Consumer Law are in addition to any remedy the local Philips entity may provide you. Throughout the remediation of this field safety notice, we will provideguidance and share next steps so you can have the most current and accurateinformation. The company has developed a comprehensive plan for this correction, and has already begun this process. December 2, 2021 (latest update) . 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. Don't have one? 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. At this time, Philips is unable to set up new patients on affected devices. Koninklijke Philips N.V., 2004 - 2023. 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. Register your product and enjoy the benefits. Philips CPAPs cannot be replaced during ship hold. After you have registered your affected device and we receive your required settings, a device will be set up and shipped to you. 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). The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone; and 2) the PE-PUR foam may off-gas certain chemicals. By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. 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. 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. 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. How to Register Your Device: Go to the Philips Respironics Recall Registration Link: Click Here. High heat and high humidity environments may also contribute to foam degradation in certain regions. Philips Quality Management System has been updated to reflect these new requirements. Should affected devices be removed from service? 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. Are affected devices safe for use? After you have registered your affected device and we receive your required settings, a device will be set up and shipped to you. No further products are affected by this issue. For more information on the Urgent Product Defect Correction in Australia and Recall for Product Correction in New Zealand, as well as instructions for customers, users and clinicians, affected parties may contact their local Philips representative or visit www.philips.com/SRC-update If you are a patient who has been affected by this correction, do not try to remove the foam from your device. 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). Call 1800-28-63-020 if you cannot visit the website or do not have internet access. Go to www.philips.com/src-update and click on "Begin registration process" (For further information, you can also scroll down to the "Patient, Users, or Caregivers" heading and then click on "Begin registration process") Select your user or customer category and choose "Australia" as the country (even if you purchased your device overseas) 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. 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. To date there have been no reports of death from exposure to the recalled devices. 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. 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. Click "Next". The FDA also issued a safety communication, Certain Philips Respironics BiPAP Machines Recalled Due to a Plastic Issue, for health care providers, patients and their caregivers. Follow those instructions. 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. Plaintiffsfiled a Second Amended Complaint in November 2022. Follow our step-by-step guide here, which includes details for return of old devices in Australia and New Zealand. Register your device (s) on Philips' recall website . 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. 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. 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. The issuance of the notification is a recall in the U.S., and field safety notice in International Markets, according to regulatory agency criteria. 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. On April 26, 2021, Philips globally provided an important update to the market regarding proactive efforts to address identified issues with a component in certain products of our Sleep & Respiratory Care portfolio. June 2021: Philips Respironics Recalls V60 and V60 Plus Ventilators Equipped with High Flow Therapy Software Versions 3.00 and 3.10 Due to Risk of Receiving Reduced Oxygen; The criminal and civil investigation is being conducted by the DOJs Consumer Protection Branch and Civil Fraud Section and the US Attorneys Office for the Eastern District of Pennsylvania, Collectiveand individual civil complaints have been filed in various jurisdictionsglobally, including but not limited to the United States, Australia,Canada, Israel and Chile. 1) PE-PUR foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user. 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). Talk with health care providers to decide if your care and treatment should change as a result of this recall. 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