The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-1626-2021·Announced 2021-06-02

Philips Respironics BiPAP A40 Ventilators Recalled for Motor Assembly Defects

Philips Respironics is recalling 10 BiPAP A40 ventilators due to non-conforming plastic in motor assemblies that may cause toxic off-gassing or sudden device failure.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk of asphyxia due to sudden device failure, which aligns with the rubric criteria for Severe severity (significant injury reports or high-risk structural defects).

Plain-English summary

Philips Respironics, Inc. is recalling 10 units of the BiPAP A40 continuous ventilator, a non-life-supporting medical device. The recall affects specific serial numbers distributed across 11 U.S. states (LA, PA, WI, CO, WV, WA, CA, TX, MO, OK, FL, and TN) as well as Brazil, China, and Japan.

The recall is due to motor assemblies that may contain non-conforming plastic material. This defect presents two primary hazards: exposure to off-gassing of Volatile Organic Compounds (VOCs) that are not normally present, creating a potential biosafety or toxicological hazard; and the potential for sudden device failure, which could render the ventilator inoperative and lead to asphyxia if not immediately identified and addressed by the care provider.

Healthcare providers and patients should identify affected units by checking the serial numbers listed in the official recall notice. If a device is found to be affected, it should be stopped and the manufacturer or FDA contacted for further instructions on replacement or repair.

The recalled product

Product
BiPAP A40, China: Continuous ventilator, non-life-supporting. Material Number - CN1111169
Manufacturer
Philips Respironics, Inc.
Category
Medical Device — Ventilators
Hazard
Affected units
10

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (10)

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

Distribution

Distributed nationwide across the United States.

The notice also names 12 states specifically:

Part of a larger recall action

This product is one of 6 recalled by Philips Respironics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

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