Recall archive / FDA device enforcement
Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 453561544461 V60 Device Part Numbers 1053617 (US) and ... — FDA record Z-2631-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Aug 25, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class I
- Recalling firm
- Philips Respironics, Inc.
- Quantity
- 15 (14 US; 1 OUS)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2631-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Distribution to states of: OH, CA, SC, OR; and OUS country of: Philippines.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Oct 4, 2023
- Recall initiation date
- Aug 25, 2023
- Center classification date
- Sep 28, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.