Philips’ Respironics Trilogy Ventilator Under FDA Class I Recall

Philips Healthcare subsidiary Respironics, Inc. has announced a worldwide recall of Respironics Trilogy Ventilators, models 100, 200, and 202.

The ventilators were recalled over concerns that they may fail to provide breathing support, reports. During production testing, Respironics discovered a faulty component on the device’s power management board. According to the U.S. Food and Drug Administration (FDA), if this issue is not corrected, the ventilator may fail to deliver mechanical breaths and the alarm function indicating ventilatory failure may be reduced, resulting in serious adverse health consequences or death. To date, there have been no reports of death or serious injury related to this problem.Class I recalls are the FDA’s most serious type of recall and involve situations in which there is a reasonable probability that use of the products will cause serious adverse health consequences or death.

The Trilogy respirators are intended for use in homes, institutions, and hospital, and in portable applications such as wheelchairs and gurneys, according to the recall notice. The recall affects 600 Trilogy respirators shipped between December 31, 2013, and January 30, 2014.

Philips Respironics advises customers to stop using the recalled respirators and return them to Philips for replacement. The company has notified customers and distributors of the recall and has provided serial numbers for affected devices. The serial number is located on the back of the respirator. The recalled devices were shipped to the United States, France, United Kingdom, Hong Kong, India, Italy, Korea, Kuwait, Netherlands, and Singapore.

Anyone with a question about the recall should contact a Philips Respironics representative via the Customer Care Center phone number: 1.800.345.6443. Assistance is available 24 hours a day, seven days a week.


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