GE Healthcare (NYSE:GE) said last week that it closed out a full field inspection of all of its Millenium MG, MC and Myosight nuclear medicine systems after an incident in which the system malfunctioned.
The company said that in September, it received notice that the top detector on on of its Millenium MG nuclear medicine systems detached and fell onto the detector below. No patients were involved and no one was injured as a result of the incident, GE said.
GE Healthcare said it launched a thorough investigation and determined that the cause of the incident was the lack of a mechanical stopper that limits detector travel and the malfunction of another primary motion stopper.
The company also launched a full, free inspection of all Millenium MG, MC and Myosight systems, advising users to discontinue use of the devices until the inspection was complete, according to a press release.
With the investigation complete, GE advised users that it found no related issues in all of its other global systems, though it added that the FDA classified the device recall as a Class I, its most extreme recall labeling indicating possible serious injury or loss of life is possible.
In its recall notice, the FDA identified the Millennium nuclear medicine systems, including the MG, MC and Myosight, manufactured between January 1, 1997 and July 1, 2012 and distributed between January 1, 1997 and September 1, 2018, with model numbers NMH817, NMH816, NMH815, NMH814, NMH803, NMH802, NMH801, NMH800, NGS014, NGS012, NGS009, NGS005 and NG00.
A total 996 units were identified in the recall, according to the FDA, who echoed the company’s reasoning for the initial error.
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