Recall Z-2631-2023— Philips Respironics, Inc.

Name: FDA recall Z-2631-2023
Creator: U.S. Food and Drug Administration
Published: 2023-08-25

Class I · Ongoing

Class I FDA medical device recall by Philips Respironics, Inc., initiated 2023-08-25. It names one FDA 510(k) clearance: K102985. Product: Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 453561544461 V60 Device Part Numbers 1053617 (US) and 1137276 (Philippines). Reason: Power Management PCBAs may malfunction, causing a power failure leading to ventilator loss of function..

Recalling firm: Philips Respironics, Inc.
Classification: Class I
Status: Ongoing
Initiated: 2023-08-25
Firm location: Murrysville, PA, 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/V60 Plus Ventilator, PCBA Part Number: 453561544461 V60 Device Part Numbers 1053617 (US) and 1137276 (Philippines)

Reason for recall

Power Management PCBAs may malfunction, causing a power failure leading to ventilator loss of function.

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