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| The Trilogy ventilator--Courtesy of Philips Respironics |
The FDA cited Philips Healthcare ($PHG) subsidiary Philips Respironics with a Class 1 recall--the agency's most serious designation--for 600 of the company's Trilogy ventilators due to an electrical defect that could result in catastrophic failure of the device.
It is the second Class 1 recall issued for one of the company's ventilators in the past year and covers Trilogy models 100, 200 and 202. In June 2013, Respironics recalled 19,000 V60 devices due to a defect with the power management system.
The Trilogy ventilator is designed to provide constant or intermittent breathing support for patients who need mechanical ventilation treatment either in hospitals and institutions, or for mobile application at home or in a wheelchair. The FDA said in issuing the Class 1 recall that "a potentially defective" component in the Trilogy ventilator power management electronics could cause the unit to fail without triggering the alarm function.
Respironics initiated the recall on Feb. 11, by phoning customers--mainly wholesale dealers--and issued a press release 8 days later with additional information about the Trilogy problems.
The FDA urges healthcare professionals and consumers to report any adverse reactions or problems related to the Trilogy ventilator through an online MedWatch program, or by regular mail or fax.
- here's the recall notice
- and here's the press release