The FDA is elevating a recall from Philips related to one of its wearable outpatient heart monitors, used to help detect ...

The FDA announced today that a Philips recall involving remote cardiac monitoring software is Class I, its most serious ...

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

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

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

Another 109 people reported injuries after using the remote cardiac monitoring software, Modern Healthcare reported. Other pharmaceutical and tech news is on the FDA's drug approval system and a rapid ...

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 ...

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 ...

and also ordered that products manufactured by Philips Lighting and sold since March 2017 be recalled and destroyed. The Court also ruled that a fine of up to €250,000 would be imposed for each ...