The Food and Drug Administration announced that Philips recalled the software following 109 reported injuries and two ...

The Class I recall, the FDA’s severest classification, is a correction and does not require removing devices from where they are used or sold. Philips started the recall on Nov. 20, 2024 ...

The FDA is elevating a recall from Philips related to one of its wearable outpatient heart monitors, used to help detect cases of hidden, transient arrhythmias that may only last minutes at a time.

Philips recalls software for mobile cardiac telemetry devices after patient injuries and deaths. Urgent medical device correction issued. Class I recall.

Some electrocardiogram events, such as atrial fibrillation or abnormally rapid heartbeats, over two years were not reviewed ...

The FDA announced today that a Philips (NYSE: PHG) + recall involving remote cardiac monitoring software is Class I, its most serious recall designation. On Dec. 18, 2024, Philips and its ...

to immediately cease the sale of certain products manufactured by affiliates of Philips Lighting brand, and also ordered the recall and destruction of infringing products distributed in the market ...