Philips BiPAP A40 System Silver Recalled for Motor Assembly Defects
Philips Respironics is recalling specific BiPAP A40 System Silver units due to non-conforming plastic in motor assemblies that may cause 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 potential for asphyxia due to sudden device failure, which aligns with the rubric criteria for Severe severity involving significant injury potential.
Plain-English summary
Philips Respironics, Inc. is recalling specific units of the BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting (Material Number: R1111177). The recall affects devices with Serial Number V30562261B40E. These units 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 recall is being conducted because certain devices were built with motor assemblies that could contain non-conforming plastic material. This defect may result in the exposure to off-gassing of Volatile Organic Compounds (VOCs) that are 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. If this failure is not immediately identified and addressed by the care provider, there is a potential for asphyxia.
Healthcare providers and consumers should identify any affected units by checking the serial number against the recall notice. If a device is found to be affected, it should be removed from service and the manufacturer contacted for instructions on repair or replacement.
The recalled product
- Product
- BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting. Material Number: R1111177
- Manufacturer
- Philips Respironics, Inc.
- Category
- Medical Device — Ventilator
- Affected units
- 1
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 (1)
- Serial Number: V30562261B40E
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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