Philips Respironics BiPAP A30 Ventilator Recall for Motor Assembly Defect
Philips Respironics is recalling two BiPAP A30 ventilators due to non-conforming plastic in motor assemblies that may cause toxic off-gassing or sudden device failure.
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 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 involving significant injury potential.
Plain-English summary
Philips Respironics, Inc. is recalling two units of the BiPAP A30 continuous ventilator (Material Number: BR1111143). The recall is issued because certain devices were built with motor assemblies that could contain non-conforming plastic material.
This defect presents two primary hazards: exposure to off-gassing of Volatile Organic Compounds (VOCs) not normally present, which creates a potential biosafety or toxicological hazard, and the potential for sudden failure of the device. A sudden failure could result in a Ventilator Inoperative condition, posing a risk of asphyxia if not immediately identified and addressed by the care provider.
The affected devices were distributed nationwide in the United States to the states of Louisiana, Pennsylvania, Wisconsin, Colorado, West Virginia, Washington, California, Texas, Missouri, Oklahoma, Florida, and Tennessee, as well as in Brazil, China, and Japan. The specific serial numbers for the recalled units are N306151248079 and N306164395E34. Users should contact the manufacturer for instructions on how to address the defect.
The recalled product
- Product
- BiPAP A30, Brazil: Continuous ventilator, non-life-supporting. Material Number: BR1111143
- Manufacturer
- Philips Respironics, Inc.
- Category
- Medical Device — Ventilator
- Affected units
- 2
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 (2)
- Serial Number: N306151248079
- N306164395E34
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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