Respironics California, Inc., a division of Philips Healthcare has completed notifying its U.S customers of a voluntary recall of 116 Respironics V60 Ventilators in the country and has confirmed that 33 have already been updated.
The recall was initiated on July 31, 2012 to address a manufacturing issue that may have affected these ventilators. Two reports of blower motor failures were received and while there were no reports of patient injury at the time of this action, Respironics California, Inc. made the decision to voluntarily replace all affected blowers.
The Respironics 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, chronic respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician.
An internal Respironics data review found that when the blower assemblies of the recalled ventilators were manufactured, the force used to press the impeller onto the blower motor shaft was less than the specified minimum force. This could result in the impeller moving up the motor shaft and coming in contact with the inside of the blower housing. 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 ventilation. This could pose a risk for injury to the patient. The V60 ventilator will alert users to malfunctioning blowers by annunciating audible and visual alarms.
Respironics California, Inc. notified the U.S. FDA of its decision to voluntarily recall the affected product on July 31, 2012.