Philips Respironics BiPAP A40 Ventilator Recall for Material Defects
Philips Respironics is recalling four BiPAP A40 ventilators because non-conforming plastic in the motor assembly 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 meets the rubric criteria for a Severe rating.
Plain-English summary
Philips Respironics, Inc. is recalling four units of the BiPAP A40 continuous ventilator (Material Number: BR1111169). The devices were distributed in the United States to Louisiana, Pennsylvania, Wisconsin, Colorado, West Virginia, Washington, California, Texas, Missouri, Oklahoma, Florida, and Tennessee, as well as in Brazil, China, and Japan. The affected serial numbers are V306120599B37, V3061207124CF, V30612105753F, and V306121267414.
The recall was initiated because certain devices were built with motor assemblies that could contain non-conforming plastic material. This defect could result in the exposure to off-gassing of Volatile Organic Compounds (VOCs) not normally present, creating a potential biosafety or toxicological hazard. Additionally, the non-conforming material could cause the device to fail suddenly, resulting in a Ventilator Inoperative condition that poses a potential risk of asphyxia if not immediately identified and addressed by the care provider.
Healthcare providers and consumers should check their inventory for the specific serial numbers listed above. If a device is found, it should be removed from service and the recalling firm contacted for instructions on repair or replacement.
The recalled product
- Product
- BiPAP A40, Brazil: Continuous ventilator, non-life-supporting. Material Number: BR1111169
- Manufacturer
- Philips Respironics, Inc.
- Category
- Medical Device — Ventilator
- 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: V306120599B37
- V3061207124CF
- V30612105753F
- V306121267414
Distribution
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.
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