We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug News
    • Trending
    • Commercial Operations
    • GMPs
    • FDA Enforcement Actions
    • Inspections and Audits
    • Postmarket Safety
    • Quality
    • Regulatory Affairs
    • Research and Development
    • Submissions and Approvals
    • FDAnews Drug Weekly
    • FDAnews
  • Device News
    • Trending
    • Commercial Operations
    • FDA Enforcement Actions
    • Inspections and Audits
    • Postmarket Safety
    • Quality
    • Regulatory Affairs
    • Research and Development
    • Submissions and Approvals
    • FDAnews Device Weekly
    • FDAnews
  • Books
    • FDAnews Books Library
    • Drug Books
    • Device Books
  • Training/Events
    • Webinar Training Pass
    • Events
  • Resources
    • Form 483s Database
    • FDA Approved Drugs
    • White Papers
  • CenterWatch
  • About Us
    • The Company
    • FDAnews Editorial Board
    • Contact Us
  • Advertising
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Philips Respironics BiPAP Machines Recalled

Philips Respironics BiPAP Machines Recalled

August 31, 2022

Philips Respironics has recalled some of its bi-level positive airway pressure (BiPAP) machines because they may contain plastic contaminated with volatile organic compounds.

The BiPAP devices are prescribed for people with obstructive sleep apnea syndrome to keep their airways open during sleep and for those who have respiratory insufficiency or respiratory failure.

If the contaminated plastic is in the device motor, it could release the organic compounds which could cause harm to patients. There is also a risk of the plastic causing the machine to fail and suddenly stop working, the FDA said in a notice on the recall.

The 386 affected machines were distributed in the U.S. between Aug. 6, 2020 and Sept. 1, 2021. No reports of serious injury or death were reported related to this issue so far, the FDA said.

View today's stories

Devices Postmarket Safety

    Upcoming Events

    • 28Sep

      The Cost of Counterfeiting: Why You Need a Plan to Secure Your Medical Device Supply Chain

    • 28Sep

      Calculating Sample Size to Satisfy FDA Expectations

    • 11Oct

      GMP Quality Management vSummit 2023: Where Quality Meets Risk

    • 16Oct

      MAGI@home Clinical Research Conference 2023

    • 26Oct

      FDA in 2024: What to Expect in an Election Year

    • 08Nov

      18th Annual FDA Inspections vSummit

    Featured Products

    • FDA, FTC and DOJ Enforcement of Medical Device Regulations

      FDA, FTC and DOJ Enforcement of Medical Device Regulations

    • Using Real-World Evidence in Drug and Device Submissions

      Using Real-World Evidence in Drug and Device Submissions

    Featured Stories

    • Manufacturing Cost is Key Issue Facing Gene Therapy Products, Marks Says

    • Artificial Womb Technology Not Yet Ready for Human Trials Adcomm Says

    • Top Concern for CBER is Marketing of Unapproved Biologics, Says FDA Official

    • FDA Deems Medline Industries’ Saline Solution Vial Recall as Class 1

    The Revised ICH E8: A Guide to New Clinical Trial Requirements

    Learn More
    • Drug Products
      • Quality
      • Regulatory Affairs
      • GMPs
      • Inspections and Audits
      • Postmarket Safety
      • Submissions and Approvals
      • Research and Development
      • Commercial Operations
    • Device Products
      • Quality
      • Regulatory Affairs
      • QSR
      • Inspections and Audits
      • Postmarket Safety
      • Submissions and Approvals
      • Research and Development
      • Commercial Operations
    • Clinical Products
      • Trial Design
      • Data Integrity
      • GCP
      • Inspections and Audits
      • Transparency
    • Privacy Policy
    • Do Not Sell or Share My Data
    Footer Logo

    300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

    Phone 703.538.7600 – Toll free 888.838.5578

    Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing