September 26, 2022

FDA: Class I recall of certain Philips Respironics BiPAP machines

By: Judy Mathias
Share

Editor's Note

The Food and Drug Administration (FDA) on September 23 identified the recall by Philips Respironics of certain models of its BiPAP machines as Class I, the most serious.

The recall was initiated because certain machines may contain a plastic contaminated with a noncompatible material. If the plastic is in the motor, it may release volatile organic compounds and cause the machine to fail suddenly during use. The risks of inhaling volatile organic compounds include headache, dizziness, nausea or vomiting, allergic reactions, and toxic and cancer-causing effects.

Product models affected are:

  • A-Series BiPAP A30 (Ventilator)
  • A-Series BiPAP A40 (Ventilator)
  • A-Series BiPAP V30 (Auto Ventilator)
  • OmniLab Advanced+.

To date, there have been no reports to the FDA of serious injuries or deaths due to the contaminated plastic issue.

Distribution dates were August 6, 2020, to September 1, 2021.

Read More >>

Get OR Manager Updates

Sign Up Now
Latest Issue of OR Manager
December 2022
Video Spotlight
Live chat by BoldChat