CLASS I ONGOING Device recall · Reported 4 Oct 2023 · FDA Enforcement Report
V60/V60 Plus Ventilator, PCBA recalled by Philips Respironics
Philips Respironics is recalling V60/V60 Plus Ventilator, PCBA, distributed in California, Ohio, Oregon, South Carolina. The recall was initiated on 25 Aug 2023 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2631-2023
- FDA event ID
- 93015
- Recalling firm
- Philips Respironics, Murrysville, PA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 25 Aug 2023
- FDA classified
- 28 Sep 2023
- Reported
- 4 Oct 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Device Malfunction
- Device type
- CPAP & Ventilators
Timeline
| 25 Aug 2023 | Recall initiated by company | |
| 28 Sep 2023 | Classified by FDA | +34 days |
| 4 Oct 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Power Management PCBAs may malfunction, causing a power failure leading to ventilator loss of function.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Philips Respironics V60/V60 Plus Ventilator, PCBA Part Number: 453561544461 V60 Device Part Numbers 1053617 (US) and 1137276 (Philippines)
Where it was distributed
US Distribution to states of: OH, CA, SC, OR; and OUS country of: Philippines.
Questions about this recall
Why was it recalled?
Power Management PCBAs may malfunction, causing a power failure leading to ventilator loss of function.
Which lots are affected?
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
Where was it sold?
US Distribution to states of: OH, CA, SC, OR; and OUS country of: Philippines.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other CPAP & Ventilators recalls
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| Device | CLASS I | Inca (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set recalled | CooperSurgical | Other | Nationwide |
| Device | CLASS I | Inca (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP recalled | CooperSurgical | Other | Nationwide |
| Device | CLASS II | Medline Hudson Rci, Dbd-circuit,Vent,Inspiratory,Heated,Neo recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | Getinge Y Sensor Module, Servo-u, Servo recalled | Maquet Critical Care AB | Device Malfunction | Nationwide |
| Device | CLASS II | Biofire Respiratory Panel 2.1 (RP2.1) recalled by BioFire Diagnostics | BioFire Diagnostics | Other | Nationwide |