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Quality / Medical Devices / Regulatory Affairs / Postmarket Safety

Philips Recalling Defective Trilogy Ventilators

Feb. 24, 2014

Philips Respironics, a subsidiary of Philips Healthcare, has initiated a voluntary worldwide recall of about 600 Trilogy ventilators due to a potentially defective component on the power management board.

According to a Feb. 19 recall notice posted to the FDA’s website, the devices contain a potentially defective ferrite component on the power management board, which could cause the ventilator to fail. Additionally, the functionality of the alarm may be reduced to indicate ventilator failure, resulting in serious adverse health consequences or death, the company said.

No deaths or injuries related to the problem have been reported, Philips said.

The recall was initiated Feb. 11 and involves models 100, 200 and 202 of the Trilogy ventilator shipped between Dec. 31, 2013, and Jan. 30. Countries affected by the recall include the U.S., UK, France, Italy, the Netherlands, India, Kuwait, South Korea, Hong Kong and Singapore.

Distributors, providers and customers who received the devices have been notified and provided with serial numbers for proper identification of affected devices, Philips said. The company is instructing customers to remove those devices and return them for replacement. — Nick Otto

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