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Two Deaths Linked To Philips Recall of Heart Monitoring Software

 
• By Brian Bossetta

A failure to properly route cardiac events has led Philips to recall its heart monitoring software that interprets ECG data. Multiple injuries and two deaths are associated with the problem.

Philips initiated a recall in November of a software application from its subsidiary Braemar Manufacturing after identifying failures to properly route some electrocardiogram (ECG) events.

The US FDA has designated the recall class I, its most serious, and says it is aware of 109 injuries and two deaths related to...

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