The Recall Desk
HighFDA (Devices)·Z-2260-2012·Announced 2012-09-12

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.

What this means for you

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 medical device that could fail to deliver life-sustaining therapy, representing a risk of harm where injury has not yet been reported, which aligns with the 'High' severity criteria for risk-of-harm products.

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 respi

Distribution

Distributed nationwide across the United States.