🔍 RecallPedia

A-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiPAP V30 Auto Continuous Ventilator, Minimum Ventilatory Support, Facility Use

Class I - Dangerous
🏥 Medical Devices Recalled: June 14, 2021 Philips Respironics Patient Monitors Nationwide

What Should You Do?

  1. Check if you have this product:
    All Devices manufactured before 26 April 2021, All device serial numbers. Material Numbers 1111181 1111182 1111178 1140184 1135427 1143671
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Philips Respironics, Inc.
Reason for Recall:
The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

A-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiPAP V30 Auto Continuous Ventilator, Minimum Ventilatory Support, Facility Use

Product Codes/Lot Numbers:

All Devices manufactured before 26 April 2021, All device serial numbers. Material Numbers 1111181 1111182 1111178 1140184 1135427 1143671

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1957-2021

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