Philips V60 Ventilator Recall for False Blower Motor Stall Detection
Respironics is recalling 2,512 Philips V60 Ventilators with Version 2.20 software because they may falsely detect a blower motor stall, causing the device to shut down and cease ventilatory support.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a critical life-support device where a software failure causes the cessation of ventilatory support. This fits the rubric criterion for 'risk-of-harm products where injury has not yet been reported,' as no specific injuries or deaths are mentioned in the source text.
Plain-English summary
Respironics California Inc is recalling 2,512 units of the Philips V60 Ventilator equipped with Version 2.20 software. The affected devices were distributed in the United States and internationally to countries including Argentina, Austria, Belgium, Canada, and others.
The recall is due to a software defect that may cause the ventilator to falsely detect that the blower motor has stalled. If this condition occurs, the software causes the ventilator to shut down, display Error Code 100E, and cease ventilatory support. The source text does not report any specific injuries or illnesses associated with this defect.
Healthcare facilities and users should check their device serial numbers against the list provided in the official recall notice. If a unit is affected, users should contact Respironics for instructions on corrective action.
The recalled product
- Product
- Philips V60 Ventilator with Version 2.20 Software, Description: V 60 Ventilator,Intl Opt: CFLEX,AVAPS,PPV V60 Ventilator,Intl Opt: CFLEX,AVAPS V60 Ventilator,Intl Opt: None V60 Ventilator,English Opt: None V60 Ventilator,Engl Opt: CFLEX,AVAPS V60 Us Demo Unit V60 USED…
- Manufacturer
- Respironics California Inc
- Category
- Medical Device — Ventilator
- Affected units
- 2,512
Distribution
Distribution scope not specified by the agency.
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