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, respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician. The V60 Ventilator is intended to support pediatric patients weighing 20kg (44 Ibs) or greater to adult patients. It is also intended for intubated patients meeting the same selection criteria as the noninvasive applications. It is intended to be used by qualified medical professionals, such as physicians, nurses, and respiratory therapists.
FDA Recall Z-2260-2012 · Posted 2012-08-31
Recalling FirmRespironics California Inc
Recall StatusTerminated
Product CodeMNT
Date Initiated2012-07-31
Date Terminated2013-03-22
Product Quantity197 units total (116 in the US)
Reason for Recall
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
Firm Action
Respironics California a division of Philips Healthcare sent a Medical Device Correction letter dated July 31, 2012 to all affected customers. The letter identified the affected product, problem identified and actions to be taken. The letter states that a Phillips Respironics Field Service Engineer or distributor will be contacting customers to schedule a no-cost replacement of the blower motor assembly on all affected V60 ventilators. For information or support concerning the recall issue, contact Philips Respironics at (800) 722-9377.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution - US (Nationwide) and the countries of: Australia, Belgium, Canada, China, Germany, Italy, Japan, Kuwait, Netherlands, Norway. Qatar, Saudi Arabia, Turkey, and United Kingdom.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.