Philips redesign prompts another Class I recall

Heart Sync is the 2nd company to face an FDA Class I recall of defibrillator electrodes due to design changes in automated external defibrillators made by Royal Philips.

Royal Philips’ (NYSE:PHG) revamped connector design for 2 of its automatic external defibrillators has left another company facing an FDA Class I recall.

This time, Michigan’s Heart Sync is dealing with the Class I recall, which the FDA assigns when there is risk of serious injury or death. Continue

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About Dan White

I'm a retired Paramedic and EMS Instructor with 35 years EMS and emergency medical product experience. I love canoes, cars and EMS. I have written a lot about EMS Technology on the Paramedic Blog, the Insights on Innovation column for EMS1.com, on AmbulanceWorld.com and Multibriefs.com. I can be reached directly at 573-240-0002.
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