News Release: HAMILTON, Bermuda – Under the Consumer Protection Act 1999, section 23 (1) a, b, c, Consumer Affairs, in partnership with Environmental Health, have undertaken the necessary recall procedures, in co-operation with the US Food and Drug Administration (“FDA”), following the recall of Philips Respironics (“Philips”) sleep and respiratory care devices. 

THE RECALL:

Philips recalls the following continuous positive airway pressure (“CPAP”) and bi-level positive airway pressure (“BiPAP”) mechanical ventilator devices manufactured before 26 April 2021. 

Type of DeviceDevice Name
Continuous Ventilator, Minimum Ventilatory Support, Facility UseE30 (Emergency Use Authorization)
Continuous Ventilator, Non-life SupportingDreamStation ASV
DreamStation ST, AVAPS
SystemOne ASV4
C-Series ASV
C-Series S/T and AVAPS
OmniLab Advanced+
Noncontinuous VentilatorSystemOne (Q-Series)
DreamStation
DreamStation Go
Dorma 400
Dorma 500
REMstar SE Auto

THE PROBLEM:

Philips recalls CPAP and BiPAP mechanical ventilator devices due to two (2) issues related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in Philips Continuous and Non-Continuous Ventilators.

Philips has identified that the PE-PUR foam may degrade into particles that may enter the device’s air pathway and be ingested or inhaled by the user and that PE-PUR foam may contain off-gas chemicals. Philips has further identified that foam PE-PUR foam degradation may be exacerbated by the use of unapproved cleaning methods, such as Ozone cleaners, which may result in off-gassing occurring during initial operation and may continue throughout the device’s useful life. These issues may result in serious injury, which may be life-threatening, cause permanent impairment, and/or require medical intervention to preclude permanent impairment.

The potential risks of particulate exposure include irritation (skin, eye and respiratory tract), inflammatory response, headache, asthma, adverse effects to other organs (e.g. kidneys and liver) and toxic, carcinogenic affects. The potential risks of chemical exposure due to off-gassing include headache/dizziness, irritation (eyes, nose, respiratory tract, skin), hypersensitivity, nausea/vomiting, toxic and carcinogenic effects.

THE REMEDY:

Consumer Affairs advises that you contact your health care provider to discuss suitable treatments and/or planned activities, which may include: 

  • Stopping use of your device;
  • Continuing to use your affected device if your health care provider determines that the benefits of continued use of your affected device outweigh the risks identified in the product recall press release.
  • Using an alternative device that is not part of the product recall or consider using alternative treatments for sleep apnea. 

Consumers are urged to find their device’s serial number and register their device on Philips’ recall website; www.philips.com/src-update. The Philips recall website provides consumers with information on:

  1. The status of the product recall.
  2. How to register your device with Philips.
  3. How to locate your device Serial Number.

If you cannot visit Philip’s official website, you may register through the Philips customer helpline: 1-877-907-7508.

After completing the registration of your Philips’ device, the Philips website will display your registration confirmation number. It is important that you keep your registration confirmation number and serial number in a safe, secure location, as Philips will ask for both in further communications. If you do not find your device on the list of Recalled Devices or during registration on the Philips website, it is advised that you contact the medical equipment supplier who provided you with your Philips device to confirm whether your device has been recalled.