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Philips Respironics, Inc. Recall 93015

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

Philips Respironics, Inc. Recall 93015 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2631-2023
Event ID93015
Event DescriptionPhilips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 453561544461 V60 Device Part Numbers 1053617 (US) and 1137276 (Philippines)
Product TypeDevices
DistributionUS Distribution to states of: OH, CA, SC, OR; and OUS country of: Philippines.
Quantity15 (14 US; 1 OUS)
Recall ReasonPower Management PCBAs may malfunction, causing a power failure leading to ventilator loss of function.
Device Classification20231004
Device Code InfoV60 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
Center Classification Date20230928
Recall Initiation Date20230825
Recalling FirmPhilips Respironics, Inc.
Initial Notification Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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