Update: Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication
The U.S. Food and Drug Administration (FDA) is updating the June 2021 safety communication on Philips Respironics recalled ventilators, BiPAP, and CPAP machines.
Thu Nov 18 2021
Date Issued: 11/12/2021
The U.S. Food and Drug Administration (FDA) is updating the June 2021 safety communication on Philips Respironics recalled ventilators, BiPAP, and CPAP machines. This update provides additional information on the recall and recommendations for people who use repaired and replaced devices. At this time, the FDA is not changing the recommendations from the prior safety communication. This update also addresses common questions and concerns from consumers, patient organizations, and health care professional societies. As the FDA continues to work diligently on this recall and develop solutions, we will continue to share information with the public and provide additional recommendations to patients and health care providers.
In June 2021, Philips Respironics recalled certain ventilators, BiPAP, and CPAP machines (see table below) because of potential health risks. The polyester-based polyurethane foam used in these devices to reduce sound and vibration can breakdown. If this occurs, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device. These issues could potentially result in serious injury, which can be life-threatening and require medical intervention to prevent permanent injury. The foam issue may get worse in hot and humid settings, and by using ozone cleaners or other cleaning methods not recommended by the manufacturer.
If you use one of these recalled devices, follow the recommendations listed below.
Philips Respironics is recalling the following devices made between 2009 and April 26, 2021.
- A-Series BiPAP A30
- A-Series BiPAP A40 (ventilator)
- A-Series BiPAP Hybrid A30
- A-Series BiPAP V30 Auto (ventilator)
- C-Series ASV (ventilator)
- C-Series S/T and AVAPS
- DreamStation
- DreamStation ASV
- DreamStation Go
- DreamStation ST, AVAPS
- Dorma 400
- Dorma 500
- E30
- Garbin Plus, Aeris, LifeVent (ventilator)
- OmniLab Advanced+
- REMstar SE Auto
- SystemOne ASV4
- SystemOne (Q-Series)
- Trilogy 100 (ventilator)
- Trilogy 200 (ventilator)
For more information, click here.