Respironics, Inc., Trilogy 100, 200, and 202 Ventilators Recalled due to Potential for Power Supply Failure

Risk Managers, Biomedical Engineering healthcare personnel and medical care organizations are notified by the FDA that Respironics, Inc., Trilogy 100, 200, and 202 Ventilators are recalled because, due to the potential for power supply failure, the possibility of unexpected cessation of patient ventilation may cause life-threatening injuries.

Background of Respironics, Inc., Trilogy 100, 200, and 202 Ventilators

Trilogy 100, 200, and 202 Ventilators, by Respironics, Inc., are used in hospitals, in the home and other healthcare settings for breathing support for patients ranging from pediatrics to adults. FDA Alert on Respironics, Inc., Trilogy 100, 200, and 202 Ventilators

FDA’s reason for the recall is that defective power supply components may cause unexpected cessation of patient’s ventilation or failure of the alarm to sound. This may lead to serious injury, including death.

The affected model/catalog numbers are:  1032800, 1040004, 1040007, 1054096, 1054260, CA1032800, R1040004, R1054655, and 1045151.

The affected product’s manufacture dates were from January 1, 2012 to April 27, 2012 and distribution dates from March 1, 2012 to May 1, 2012.

The FDA classified this recall as Class I, meaning use of the products included in the recall may cause serious injuries or death.

Recommendation on Respironics, Inc., Trilogy 100, 200, and 202 Ventilators

“The recall was initiated April 27, 2012 and Respironics, Inc. began contacting their affected U.S. customers by phone. The firm requested customers to quarantine any affected devices within their possession and to retrieve any devices with patients and quarantine those as well. The company will provide replacement devices to all affected customers. In the time period prior to Respironics replacing the device, the patient’s health care providers should provide an alternative device. Affected customers may contact Respironics Customer Service at 1-877-387-3311.”

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