Devices & Diagnostics

FDA hits Respironics with a Class I recall over defective ventilators

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 […]

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.

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