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)
- FDA Device
- Class I
- ongoing
- Published 2023-10-04
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
| Agency | FDA Device |
|---|---|
| Recall number | Z-2631-2023 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-08-25 |
| Published | 2023-10-04 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Philips Respironics |
| Distribution | CA, 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
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