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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:195438

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

Official recall number

Z-1654-2022

Evidence summary

Product code
MNS
Recall status
Open, Classified
Event initiated
August 26, 2022
Root cause
Process control
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-1654-2022