Recall Z-0907-2022— Respironics California, LLC

Name: FDA recall Z-0907-2022
Creator: U.S. Food and Drug Administration
Published: 2022-02-28

Class I · Ongoing

Class I FDA medical device recall by Respironics California, LLC, initiated 2022-02-28. It names one FDA 510(k) clearance: K102985. Product: Philips Respironics V60 Ventilator (All Models, including: 1053613, 1053614, 1053615, 1053616, 1053617, 1053618, 1076709, 1076716, 1076717, 1137292, DU1053617, U1053617, R1053618, R1076709). Reason: Ventilator units have an issue impacting an internal electrical circuit within the ventilators, that in some cases could result in the ventilator ceasing to operate..

Recalling firm: Respironics California, LLC
Classification: Class I
Status: Ongoing
Initiated: 2022-02-28
Firm location: Carlsbad, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K102985 — V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONSRespironics, Inc.·cleared 2011-04-05

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 Respironics V60 Ventilator (All Models, including: 1053613, 1053614, 1053615, 1053616, 1053617, 1053618, 1076709, 1076716, 1076717, 1137292, DU1053617, U1053617, R1053618, R1076709)

Reason for recall

Ventilator units have an issue impacting an internal electrical circuit within the ventilators, that in some cases could result in the ventilator ceasing to operate.

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