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Philips Healthcare's Respironics, Inc. (RESP) Issues Another Ventilator Recall


9/4/2012 8:54:49 AM

WASHINGTON, Aug. 31 -- The U.S. Department of Health & Human Services' Food & Drug Administration issued the following recall notice:

Respironics California, Inc., a division of Philips Healthcare announced today that it has completed notifying its United States customers of a voluntary recall of 116 Respironics V60 Ventilators in the United States 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.

Customers who have questions about the recall may contact a Philips Respironics representative at 800 722-9377.

Please see attached serial number list of affected units that were recalled.

Respironics California, Inc. notified the U.S. Food & Drug Administration (FDA) of its decision to voluntarily recall the affected product on July 31, 2012. Any adverse reactions experienced with the use of this product should be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch. Adverse reactions and/or quality problems should also be reported to Philips Respironics at 1-800 -722-9377.

RSS Feed for FDA Recalls Information [what's this?]

(http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/Recalls/rss.xml)

PDF Of Affected Serial Numbers (http://www.fda.gov/downloads/Safety/Recalls/UCM317944.pdf)

TNS MT93 120901-4009992 61MarlizTagarum



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