GE Healthcare has completed inspections of all its gamma cameras in the U.S. after an incident in September during which a top detector detached and fell onto the detector below it.
No patients were involved in the incident and no injuries were reported as a result of the detector's detachment. However, the accident prompted GE to issue a recall of all of its Millennium MG, Millennium MC, and Millennium MyoSight systems. The U.S. Food and Drug Administration (FDA) classified GE's action as a class I recall, the agency's most serious type of recall, which indicates use of the devices "may cause serious injuries or death."
The gamma cameras involved in the recall were manufactured by GE between January 1, 1997, and July 1, 2012, and distributed from January 1, 1997, to September 1, 2018, according to the FDA. The recall notice covered 996 devices in the U.S.
In a September 14 communiqué to its customers, GE recommended at that time that all sites suspend their use of the three gamma camera models until the company could complete a full and free inspection of all systems.
GE determined that the cause of the detector malfunction was a missing mechanical "stopper" designed to limit detector movement during normal operation. In addition, another primary motion stopper did not operate properly, according to both GE and the FDA.
On November 6, GE reported that all of its inspections had been completed, and there were no other related issues for any of its global systems.
