Philips Respironics V60 Ventilator Recalled Due to Electrical Circuit Defect
Philips Respironics V60 ventilators are recalled due to an internal electrical circuit defect that may cause the device to stop operating. Approximately 87,138 units worldwide are affected.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification mandates minimum severity of 4. The hazard—internal electrical circuit failure causing potential ventilator shutdown—presents direct risk to patients dependent on mechanical ventilation. No deaths or hospitalizations reported in source.
Plain-English summary
Philips Respironics V60 ventilators are the subject of an FDA Class I recall. The recall affects approximately 87,138 units distributed worldwide and across all US states, including multiple model variants of the V60 system.
The recall is due to an internal electrical circuit defect that in some cases could cause the ventilator to cease operating. This loss of function poses a risk to patients dependent on the device for respiratory support.
All lots and serial numbers of the affected models are included in the scope of this recall.
The recalled product
- Product
- Philips Respironics V60 Ventilator (All Models, including: 1053613, 1053614, 1053615, 1053616, 1053617, 1053618, 1076709, 1076716, 1076717, 1137292, DU1053617, U1053617, R1053618, R1076709)
- Manufacturer
- Respironics California, LLC
- Category
- Medical Device — Ventilator
- Affected units
- 87,138
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- All Lots & Serial Numbers. V60 UDI-DI: 00884838009844
- 00884838009851
- 00884838020054
- 00884838025776
- 00884838089280
- 00884838090996.
Distribution
Part of a larger recall action
This product is one of 3 recalled by Respironics California, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Respironics California, LLC
See all →- SeverePhilips Respironics V60 Plus Ventilator Recalled for Electrical Circuit Failure Risk
FDA (Devices) · 2022-04-27
- SeverePhilips Respironics V680 Ventilator May Stop Operating Due to Electrical Fault
FDA (Devices) · 2022-04-27
- SeverePhilips Respironics V60 Plus Ventilators with Defective Adhesive Recalled
FDA (Devices) · 2022-03-09
- SeverePhilips V60 Ventilator Recall: Expired Adhesive May Cause Device Failure
FDA (Devices) · 2022-03-09
- SeverePhilips Respironics V60 Ventilator Flow Rate Reduction Safety Defect
FDA (Devices) · 2021-07-28
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