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.
Earlier in December, a ConMed (NSDQ:CNMD) recall was hit with a Class I label because the Philips design changes left some of its electrode models unable to work with the updated devices.
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