Respironics Inc, a Philips Healthcare business, has issued a worldwide recall of approximately 600 Philips Respironics Trilogy Ventilators, comprising Trilogy Ventilator Models 100, 200 and 202, according to the company.
A potentially defective component on the Trilogy Ventilator power management board could affect the function of the device, Respironics said in the recall notice. If this issue is not corrected it is possible that the ventilator may fail to deliver mechanical breaths and that the alarm functionality may be reduced to indicate ventilatory failure, resulting in serious adverse health consequences or death.
There have been no reports of death or serious injury related to this potential problem, Respironics noted in the recall notice.
The recall affects 600 Trilogy Ventilator devices shipped between December 31, 2013, and January 30, 2014.
Countries where affected devices have been shipped include the United States, France, United Kingdom, Hong Kong, India, Italy, Korea, Kuwait, Netherlands, and Singapore.
Philips Respironics is instructing customers to remove affected devices from service and to return them to Philips for replacement. All distributors, providers, and customers with potentially affected Trilogy devices will have their units replaced, the company noted.