Recall Z-1657-2022— Philips Respironics, Inc.

Name: FDA recall Z-1657-2022
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: K090248. Product: Philips OmniLab Advanced+, 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

K090248 — BIPAP AUTOSVRespironics Inc., Sleep & Home Respiratory Group·cleared 2009-03-04

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+, 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.