Philips BiPAP A40 Respiratory Devices Recalled for Motor Assembly Off-Gassing
Philips is recalling BiPAP A40 respiratory support devices because motor assemblies were manufactured with nonconforming plastic that off-gases volatile organic compounds (VOCs). Approximately 1,414 units have been distributed domestically and internationally.
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: FDA Class I classification requires a minimum severity score of 4. The recall involves chemical hazard (VOC off-gassing) in respiratory support devices used by vulnerable populations. No illnesses or injuries are reported.
Plain-English summary
Philips Respironics, Inc. is recalling Philips BiPAP A40 devices, which provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome and respiratory insufficiency.
The recall affects 1,091 units distributed in the United States and 323 additional units distributed internationally (updated January 2024). The devices have been distributed across all U.S. states and to 23 countries including Australia, Brazil, Canada, France, Germany, Japan, Mexico, and the United Kingdom.
The motor assemblies in the recalled devices were manufactured with nonconforming plastic that contributes to off-gassing of volatile organic compounds (VOCs). This chemical exposure presents a potential health risk to patients who depend on these respiratory support devices.
The recalled product
- Product
- Philips BiPAP A40, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
- Manufacturer
- Philips Respironics, Inc.
- Hazard
- voc-offgassing
- chemical-exposure
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 (20)
- UDI-DI: 606959042742
- 606959042766
- 606959042797
- 606959067677
- 606959067714
- 606959042834
- 606959067752
- 606959067721
- 606959068025
- Model No.: 1109596
- 1109598
- 1109601
- 1111169
- 1111177
- 1116153
- 1116156
- CN1111169
- R1111177
- Serial No.: V287427181CF7
- V28772370BAC2
Distribution
Distributed in 42 states:
- 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
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