Philips BiPAP A30, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
Reported: September 14, 2022 Initiated: August 26, 2022 #Z-1654-2022
Product Description
Philips BiPAP A30, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
Reason for Recall
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
Details
- Recalling Firm
- Philips Respironics, Inc.
- Units Affected
- 146 units ***updated January 2024*** 30 additional units
- Distribution
- Domestic: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, TN, TX, VA, VT, WA, WI, WV, & WY. Foreign: 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, UAE, & UK.
- Location
- Murrysville, PA
Frequently Asked Questions
What product was recalled? ▼
Philips BiPAP A30, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.. Recalled by Philips Respironics, Inc.. Units affected: 146 units ***updated January 2024*** 30 additional units.
Why was this product recalled? ▼
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 14, 2022. Severity: Critical. Recall number: Z-1654-2022.
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