Philips BiPAP A30 respiratory device motor assemblies recalled for VOC off-gassing

Plain-English summary

Philips Respironics is recalling Philips BiPAP A30 respiratory devices, which provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency. The motor assemblies in these devices were manufactured with nonconforming plastic.

The nonconforming plastic contributes to off-gassing of volatile organic compounds (VOCs). The FDA classified this as a Class I recall, the most serious medical device classification, indicating a reasonable probability that the recalled product could cause serious adverse health consequences or death.

Approximately 146 units are affected domestically across all U.S. states, with an additional 30 units identified in January 2024. The devices have also been distributed internationally to Australia, Austria, Bangladesh, Brazil, Canada, China, Denmark, Egypt, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Myanmar, Philippines, Qatar, Serbia, Singapore, Taiwan, Thailand, Turkey, United Arab Emirates, and the United Kingdom.

Patients using Philips BiPAP A30 devices should contact Philips Respironics immediately for guidance on replacement, repair, or return of their devices. Healthcare providers should inform affected patients about this recall and ensure appropriate follow-up care.

The recalled product

Product

Philips BiPAP A30, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.

Manufacturer

Philips Respironics, Inc.

Category

Medical Device — Respiratory support device

Hazard

• voc-off-gassing
• manufacturing-defect

Is your product affected?

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

Distribution

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