Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2260-2012 — 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 respiratory failure, resp

U.S. FDA — Device Enforcement · United States · 2012-07-31 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2260-2012
Date of alert
2012-07-31
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Respironics California Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
100026615
Reported risk: 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 subsequently 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 ventilatio
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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