MASSDEVICE ON CALL — Philips Healthcare (NYSE:PHG) subsidiary Respironics got the FDA’s highest-level warning over a recall of certain Trilogy ventilators.
The devices were recalled over concerns that they may fail to provide breathing support. Respironics attributed the error to a faulty component on the device’s power management board, discovered during production testing.
The company initiated the recall last month, saying that the glitch may exist in Trilogy models 100, 200, and 202. The measure affects some 600 devices shipped in the U.S., France, United Kingdom, Hong Kong, India, Italy, Korea, Kuwait, the Netherlands and Singapore between Dec. 31, 2013, and Jan. 30, 2014.
The new warnings are the 2nd such Respironics recall in the past year. In June 2013, the FDA issued another Class I label on a recall of more than 19,000 V60 ventilators, also over a problem with power management systems.
The FDA applies its Class I label to recalls considered to be the most dangerous, those that may pose a risk of injury or death to patients.
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