Philips Respironics, Inc.: Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 453561544461 V60 Device Part Numbers 1053617 (US) and 1137276 (Philippines)

Hazard

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

Details from the source

Reason for recall: Power Management PCBAs may malfunction, causing a power failure leading to ventilator loss of function. Distribution: US Distribution to states of: OH, CA, SC, OR; and OUS country of: Philippines. Quantity: 15 (14 US; 1 OUS) Lot/code info: V60 Device Serial # /PCBA Serial # 201019564 SC23120K8 201014394 SC23120NH 201017048 SC2312133 100246411 SC231116C 100246416 SC231117H 100085632 SC2311127 100013579 SC23110EV 100082334 SC2311138 ***Updated November 6, 2023*** 100423818 SC2311168 100293267 SC2312154 100006900 SC2311165 100006889 SC23110MF 201010175 SC231104X (Philippines) ***Updated July 23, 2024*** 100385387 SC231108T 201029990 SC2311055

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.