🔍 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

Related Recalls

SimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected battery kits are sold as accessories for the SimplyGo Mini: SimplyGo Mini Portable Oxygen Concentrator Product code: 1113600

Philips Respironics

Class I - Dangerous

Certain serial numbers of the SimplyGo Mini standard battery kit contain a defective chip which can lead the battery to either fail to charge or lose voltage output when in use in the device. If the fault occurs while the device is running on battery power, the SimplyGo Mini will shut down and stop providing oxygen to the user. This may happen at a temperature within the specified operating temperature range of the SimplyGo Mini.

Oct 7, 2025 Other Medical Devices Nationwide View Details →