Recall Z-1958-2021— Philips Respironics, Inc.

Name: FDA recall Z-1958-2021
Creator: U.S. Food and Drug Administration
Published: 2021-06-14

Class I · Ongoing

Class I FDA medical device recall by Philips Respironics, Inc., initiated 2021-06-14. It names 2 FDA 510(k) clearances: K121623, K113053. Product: A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Supporting. Reason: The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals..

Recalling firm: Philips Respironics, Inc.
Classification: Class I
Status: Ongoing
Initiated: 2021-06-14
Firm location: Murrysville, PA, United States

510(k) clearances named in this recall

2 on FDA's record

K121623 — BIPAP A 40 VENTILATORY SUPPORT SYSTEMRespironics, Inc.·cleared 2012-12-14
K113053 — BIPAP A 30 VENTILATORY SUPPORT SYSTEMRespironics, Inc.·cleared 2012-02-01

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

A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Supporting

Reason for recall

The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.

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