Recall Z-1658-2022— Philips Respironics, Inc.

Name: FDA recall Z-1658-2022
Creator: U.S. Food and Drug Administration
Published: 2022-08-26

Class I · Ongoing

Class I FDA medical device recall by Philips Respironics, Inc., initiated 2022-08-26. It names one FDA 510(k) clearance: K090539. Product: Philips OmniLab Advanced+ Intl (Flow Gen), 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

510(k) clearances named in this recall

1 on FDA's record

K090539 — BIPAP AUTOSV ADVANCEDRespironics Inc., Sleep & Home Respiratory Group·cleared 2009-10-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Philips OmniLab Advanced+ Intl (Flow Gen), 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.