🔍 RecallPedia

BiPAP A40, China: Continuous ventilator, non-life-supporting. Material Number - CN1111169

Class I - Dangerous
🏥 Medical Devices Recalled: April 6, 2021 Philips Respironics Patient Monitors Nationwide

What Should You Do?

  1. Check if you have this product:
    Serial Number: V30446637ACAE, V30446653BE5A, V304441360854, V304457587F98, V304468408502, V304441766F34, V3044555732D7, V30446846E034, V30444034719A, V3044642346EA.
  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:
Certain devices were built with motor assemblies that could contain non-conforming plastic material. This could result in 1. Exposure to off-gassing of Volatile Organic Compounds not normally present creating a potential biosafety or toxicological hazard and 2. Sudden failure of the device causing a Ventilator Inoperative condition with the potential for asphyxia if not immediately identified and addressed by the care provider.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

BiPAP A40, China: Continuous ventilator, non-life-supporting. Material Number - CN1111169

Product Codes/Lot Numbers:

Serial Number: V30446637ACAE, V30446653BE5A, V304441360854, V304457587F98, V304468408502, V304441766F34, V3044555732D7, V30446846E034, V30444034719A, V3044642346EA.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1626-2021

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