The Recall Desk
SevereFDA (Devices)·Z-1628-2021·Announced 2021-06-02

Philips Respironics BiPAP A40 System Silver Recalled for Motor Assembly Defect

Philips Respironics is recalling four BiPAP A40 System Silver units due to non-conforming plastic in motor assemblies that may off-gas or fail, posing asphyxia risks.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text explicitly identifies a potential for asphyxia due to sudden device failure, which constitutes a significant injury risk under the rubric for Severe recalls.

Plain-English summary

Philips Respironics, Inc. is recalling four units of the BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting (Material Number: 1111177). The recall involves specific serial numbers: V305622168DB9, V30562335D64E, V305626872849, and V30562903EA6A. The devices were distributed nationwide in the United States to Louisiana, Pennsylvania, Wisconsin, Colorado, West Virginia, Washington, California, Texas, Missouri, Oklahoma, Florida, and Tennessee, as well as to Brazil, China, and Japan.

The recall is due to motor assemblies that may contain non-conforming plastic material. This defect could result in the exposure of Volatile Organic Compounds (VOCs) not normally present, creating a potential biosafety or toxicological hazard. Additionally, the defect could cause sudden device failure, rendering the ventilator inoperative. If this failure is not immediately identified and addressed by a care provider, it poses a potential risk of asphyxia.

Healthcare providers and consumers should check their device serial numbers against the list provided. If the device is affected, it should be removed from service and returned to Philips Respironics for evaluation and repair or replacement.

The recalled product

Product
BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting. Material Number: 1111177
Manufacturer
Philips Respironics, Inc.
Category
Medical Device — Ventilator
Hazard
Affected units
4

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 (4)

  • Serial Number: V305622168DB9
  • V30562335D64E
  • V305626872849
  • V30562903EA6A

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 →

Related recalls

Same manufacturer · Philips Respironics, Inc.

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Same hazard · asphyxia

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