Recall of Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Due to Potential Health Hazards: FDA Safety Communication

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Date Issued: June 30, 2021

To protect the health of individuals who use Philips Respironics ventilators, BiPAP, and CPAP machines, the U.S. Food and Drug Administration (FDA) is warning people and their health care providers, that Philips Respironics has recalled some equipment owing to possible health hazards (see table below). Polyurethane-based polyester sound dampening foam (PE-PUR) may deteriorate and enter the device’s air route. Some harmful materials may be breathed or ingested if this problem arises.

These impacted devices are mentioned in the table below, and if you have one, discuss an appropriate treatment with your healthcare provider.

Philips Respironics is recalling the following affected devices manufactured between 2009 and April 26, 2021. For details, see Philips’ Respironics recall notification External Link Disclaimer (PDF).

 

CPAP and BiPAP Devices

Device TypeModel Name and Number (All Serial Numbers)
Continuous Ventilator, Minimum Ventilatory Support, Facility Use ·E30 (Emergency Use Authorization)
Continuous Ventilator, Non-life Supporting· DreamStation ASV
· DreamStation ST, AVAPS
· SystemOne ASV4
· C-Series ASV
· C-Series S/T and AVAPS
· OmniLab Advanced
Noncontinuous Ventilator· SystemOne (Q-Series)
· DreamStation
· DreamStation Go
· Dorma 400
· Dorma 500
· REMstar SE Auto

Ventilators

Device TypeModel Name and Number (All Serial Numbers)
Continuous Ventilator· Trilogy 100
· Trilogy 200
· Garbin Plus, Aeris, LifeVent
Continuous Ventilator, Minimum Ventilatory Support, Facility Use· A-Series BiPAP Hybrid A30 (not marketed in US)
· A-Series BiPAP V30 Auto
Continuous Ventilator, Non-life Supporting· A-Series BiPAP A40
· A-Series BiPAP A30

 

BiPap or CPAP: Recommendations for People Who Use Affected BiPAP or CPAP Machines and Caregivers

Decide on an appropriate therapy for your condition with your provider. This may include:

  • Stopping use of your device
  • Using another similar device that is not part of the recall.
  • Continuing to use your affected device, if your health care provider determines that the benefits outweigh the risks identified in the recall notice.
  • Using alternative treatments for sleep apnea, such as positional therapy or oral appliances, which fit like a sports mouth guard or an orthodontic retainer.
  • Initiating long term therapies for sleep apnea, such as losing weight, avoiding alcohol, stopping smoking, or, for moderate to severe sleep apnea, considering surgical options.

Questions?

The FDA posted answers to frequently asked questions about this recall: Philips Respiraonics CPAP, BiPAP, and Ventilator Recall: Frequently Asked Questions.

For more information on the recall notification, contact your local Philips representative or visit Philips Respironics’ recall notification web page External Link Disclaimer.

More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov.

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Health · Medical · Prevention · Technology · Uncategorized

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