Philips Respironics Sleep and Respiratory Care devices
Device registration and recall contact information
On June 14, 2021, Philips issued a recall notification for the United States for specific affected ventilation and sleep apnea devices. The notification informs patients, users and customers of potential impacts on patient health and clinical use related to this issue. Read below to learn more about the recall, determine if your device is impacted, and next steps to register your device.
There is nothing we take more seriously than providing patients with high quality products that are safe and reliable. If an issue arises, we are proactive in communicating and addressing it as we work tirelessly towards a resolution.
Philips is committed to rectfying this issue through a robust and comprehensive repair and replacement program. We have established a claims processing and support center to assist you.
What devices are affected by the recall notification / field safety notice?
The recall notification (U.S. only) / field safety notice (Outside of U.S.) provides customers with information on how to identify affected products.
Additionally, the device Instructions for Use provide product identification information to assist with this activity.
Products listed in this notification include:
- A-Series BiPAP V30 Auto Ventilator Also known as BiPAP V30 Auto
- C Series S/T, AVAPS
- Continuous Ventilator, Minimum Ventilatory Support, Facility Use E-30
- DreamStation ASV
- DreamStation CPAP, Auto CPAP, BiPAP
- DreamStation GO CPAP, APAP, Auto CPAP
- DreamStation ST, AVAP
- OmniLab Advanced Plus
- System One 60 series
- SystemOne ASV4
- Trilogy 100 Ventilator
- Trilogy 200 Ventilator
On April 26, 2021, Philips provided an important update regarding proactive efforts to address identified issues with a component in certain products of our Sleep & Respiratory Care portfolio.
At that time, out of an abundance of caution and based on available information, Philips advised of potential health risks related to sound abatement foam used in specific Philips Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators. The company also indicated that analysis of potential health risks was ongoing, and that further information would be provided when available.
As a result of extensive ongoing analysis following this announcement, on June 14, 2021, the company issued a recall notification (U.S. only) / field safety notice (Outside of U.S.) for specific affected devices.
The notification informs customers and users of potential impacts on patient health and clinical use related to this issue. 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. High heat and high humidity environments may also contribute to foam degradation in certain regions.
At the time of the June 2021 recall / field safety notice, Philips had received a limited number of reports of possible patient impact due to foam degradation, and no reports regarding patient impact related to chemical emissions. Philips continues to monitor complaints received following the recall / field safety notice via our Quality Management System, in accordance with the medical devices regulations and laws in the markets that we serve.
The notification advises patients and customers to take the following actions:
- For patients using BiLevel PAP and CPAP devices: Discontinue use of affected units and consult with physicians to determine the benefits of continuing therapy and potential risks.
- For patients using life-sustaining mechanical ventilator devices: DO NOT discontinue or alter prescribed therapy, without consulting physicians to determine appropriate next steps.
Philips is recommending that customers and patients do not use ozone-related cleaning products.
Additionally, Philips is reminding customers and patients to review the age of their BiLevel PAP and CPAP devices, as they are recommended to be replaced after five years of use.
We are treating this matter with the highest possible seriousness, and are working to address this issue as efficiently and thoroughly as possible.
The company has developed a comprehensive plan to replace the current sound abatement foam with a new material that is not affected by this issue, and has already begun this process.