On Thursday, the U.S. Food and Drug Administration classified Philips Respironics’ voluntary recalls of faulty ventilators as a Class I recall.
Philips Respironics recalled the Trilogy 100, 200 and 202 ventilators in late April that were manufactured in the first four months of the year and sold between March 1 and May 1. These ventilators aimed at infants weighing at least 11 pounds as well as adults were found to contain some defective parts in their power supplies.
If the power supply fails, then the device stops functioning and it may also fail to sound an alarm. For these reasons, the FDA deemed the recall a Class I, the most serious.
In 2008, Royal Philips bought Respironics, a maker of obstructive sleep apnea treatment devices, for $5.1 billion.
[Photo Credit: FreeDigitalPhotos.net]
By Arundhati Parmar
Arundhati Parmar is the Medical Devices Reporter at MedCity News. She has covered medical technology since 2008 and specialized in business journalism since 2001. Parmar has three degrees from three continents - a Bachelor of Arts in English from Jadavpur University, Kolkata, India; a Masters in English Literature from the University of Sydney, Australia and a Masters in Journalism from Northwestern University in Chicago. She has sworn never to enter a classroom again.More posts by Author
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