MURRYSVILLE, Pa., Jan. 12, 2012 /PRNewswire/ -- Respironics, Inc. announced today that it has completed notifying customers of a voluntary recall of 52 Trilogy Model 100 ventilators in the United States and has confirmed that 51 have already been removed from use. The recall was initiated on October 11, 2011 to address a manufacturing issue that may have affected these ventilators. Respironics received no reports of ventilator malfunctions, failures or injuries related to this issue.
The Trilogy 100 ventilator provides portable volume and pressure support ventilation for adult and pediatric use in both invasive and noninvasive applications. Other Trilogy ventilator models distributed in the United States, the Trilogy 200 and 202, were not affected by this recall.
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. If this were to occur, it could cause noise, the sounding of an inoperative ventilator alarm, or a blower failure. In the event of a blower failure, the ventilator would stop delivering therapy and a high priority alarm would sound to alert the caregiver to immediately respond. Failure to respond could result in the potential for harm or death of a ventilator dependent patient.
Respironics began notifying its United States distributors, providers, sales personnel and customers of the recall by telephone on October 11, 2011. Although the Respironics customers who received the affected units have already confirmed receipt of our notice, customers who have questions about the recall may contact Respironics Customer Service at 1-877-387-3311. Please see attached serial number list of affected units that were recalled.
Respironics notified the U.S. Food & Drug Administration (FDA) of its decision to voluntarily recall the affected product on October 7, 2011. 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 Respironics at 1-877-387-3311.
Serial Numbers of Domestic Devices RecalledTV111021835
|SOURCE Respironics, Inc.|
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