Tag Archive for: device recall

The U.S. Food and Drug Administration (FDA) said it is still not satisfied with how Dutch healthcare technology company Philips has handled a major product recall and the company should conduct additional risk testing.

Dutch medical devices maker Philips said on Tuesday that independent tests have shown that the use of its respiratory devices involved in a major global recall did not cause health risks for patients.

The U.S. Food and Drug Administration (FDA) on Friday classified the recall of Philips’ respiratory machines as its most serious type, as their use could cause serious injuries or death.

The Class I recall affects nearly 250,000 devices.