Philips Respironics V680 Ventilator May Stop Operating Due to Electrical Fault
Philips Respironics V680 Ventilators may stop operating due to an internal electrical circuit fault. Units were distributed worldwide and across the United States.
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 recall of a life-critical respiratory device with potential for internal electrical failure causing cessation of operation. No illnesses or injuries are reported. FDA Class I recalls warrant a minimum severity score of 4 per the established rubric.
Plain-English summary
Respironics California, LLC is recalling Philips Respironics V680 Ventilators (all models, including part number 1103044 (850011)) due to a potential internal electrical circuit issue.
The affected ventilators may experience a malfunction in an internal electrical circuit that could cause the device to cease operating. This poses a serious risk to patients who depend on the ventilator for respiratory support.
The ventilators were distributed worldwide and throughout the United States, including all 50 states and Washington D.C.
Patients and healthcare providers should contact Respironics California, LLC or consult their healthcare provider for information about this recall and appropriate next steps.
The recalled product
- Product
- Philips Respironics V680 Ventilator (All Models, including: P/N 1103044 (850011)), *Distributed outside the United States
- Manufacturer
- Respironics California, LLC
- Category
- Medical Device — Ventilator
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 (2)
- All Lots & Serial Numbers
- *Distributed outside the Untied States
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.
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