V60 Ventilator, Continuous Ventilator, Model# V60, PN 1056490 Product Usage: The V60 Ventilator is an assist Ventilator

FDA device recall Z-2260-2012 · posted 2012-08-31 · Terminated

Recall details

Recalling firm

Respironics California Inc

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

Action taken

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

Status

Terminated

Product code

MNT

Quantity affected

197 units total (116 in the US)

Distribution

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.

Date initiated

2012-07-31

Date posted

2012-08-31

Date terminated

2013-03-22

Location

Carlsbad, CA

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