Device product

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

Z-2631-2023

August 25, 2023

Class I

Product summary

Firm: Philips Respironics, Inc.
Event: Event 93015
Status: Ongoing
Classification: Class I
Quantity: 15 (14 US; 1 OUS)
Official record key: device-enforcement:Z-2631-2023

Official wording

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

Code information: 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

Distribution pattern: US Distribution to states of: OH, CA, SC, OR; and OUS country of: Philippines.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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