Recall Z-1656-2022— Philips Respironics, Inc.
Class I · Ongoing
Class I FDA medical device recall by Philips Respironics, Inc., initiated 2022-08-26. FDA's recall record names no specific 510(k) clearance for this event. Product: Philips BiPAP V30 Auto, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.. Reason: Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs..
- Recalling firm
- Philips Respironics, Inc.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2022-08-26
- Firm location
- Murrysville, PA, United States
Product description
Philips BiPAP V30 Auto, 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.