Respironics Recalls V60 Ventilators Due to Blower Motor Assembly Defect
Respironics is recalling V60 ventilators because blower motor assemblies may not meet specifications, potentially causing the device to stop delivering therapy.
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: The agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Respironics is recalling the V60 ventilator because certain blower motor assemblies in the V60 ventilators may not meet specifications. Specifically, the impeller may not be properly seated on the blower motor shaft. This could…"
Plain-English summary
Respironics is recalling the V60 ventilator because certain blower motor assemblies in the V60 ventilators may not meet specifications. Specifically, the impeller may not be properly seated on the blower motor shaft.
This defect could cause the blower to cease functioning, which would result in the failure of the V60 ventilator to deliver therapy to the patient due to the loss of ventilation. The V60 Ventilator is an assist ventilator intended to augment patient breathing for spontaneously breathing individuals who require mechanical ventilation, including patients with respiratory failure, respiratory insufficiency, or obstructive sleep apnea in hospital or other institutional settings.
A total of 197 units are affected, with 116 units distributed in the United States. The remaining units were distributed worldwide in Australia, Belgium, Canada, China, Germany, Italy, Japan, Kuwait, Netherlands, Norway, Qatar, Saudi Arabia, Turkey, and the United Kingdom. Affected units are identified by specific serial numbers listed in the recall documentation.
The recalled product
- Product
- V60 Ventilator, Continuous Ventilator, Model# V60, PN 1056490 Product Usage: The V60 Ventilator is an assist Ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with…
- Manufacturer
- Respironics California Inc
- Category
- Medical Device — Ventilator
Distribution
Distributed nationwide across the United States.
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