Recall Z-2037-2025— Philips Respironics, Inc.

Name: FDA recall Z-2037-2025
Creator: U.S. Food and Drug Administration
Published: 2025-05-09

Class I · Ongoing

Class I FDA medical device recall by Philips Respironics, Inc., initiated 2025-05-09. It names one FDA 510(k) clearance: K121623. Product: BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients. BiPAP A40 Pro - sold OUS. Reason: This device does not indicate for use in patients with respiratory failure..

Recalling firm: Philips Respironics, Inc.
Classification: Class I
Status: Ongoing
Initiated: 2025-05-09
Firm location: Murrysville, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K121623 — BIPAP A 40 VENTILATORY SUPPORT SYSTEMRespironics, Inc.·cleared 2012-12-14

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

BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients. BiPAP A40 Pro - sold OUS

Reason for recall

This device does not indicate for use in patients with respiratory failure.

Data sourced from openFDA. This site is unofficial and independent of the FDA.