GE—Millennium MC, Millennium MG, and Millennium MYOSIGHT Systems: Detector May Detach and Fall onto Detector below It
October 3, 2018 | Risk Management News
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In a September 14, 2018, Urgent Medical Device Correction letter submitted by an ECRI Institute member hospital, GE states that a detector of the above systems may fall onto the detector below, potentially leading to life-threatening harm if the detector falls during a patient exam. GE also states that this problem is caused by a motion subsystem error and a missing mechanical stopper that prevents the detector from traveling beyond its limits. GE further states that it has received no reports...