RecallRadar

FDA Device recall Z-2631-2023

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

On 2023-10-04 the FDA classified a Class I recall of Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 453561544461 V60 Device Part Numbers 1053617 (US) and 1137276 (Philippines) by Philips Respironics, citing power Management PCBAs may malfunction, causing a power failure leading to ventilator loss of function.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2631-2023
ClassificationClass I
Statusongoing
Initiated2023-08-25
Published2023-10-04
Last updated2026-09-13 11:56 UTC
CompanyPhilips Respironics
DistributionCA, OH, OR, SC

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.

Identifiers

code_info
V60 Device Serial # /PCBA Serial # 201019564 SC23120K8 201014394 SC23120NH 201017048 SC2312133 100246411 SC231116C…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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2631-2023%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.