GE Healthcare is recalling the Millennium Nuclear Medicine Systems due to an incident in which the top detector detached and fell onto the detector below it. At present this recall includes 996 devices manufactured between January 1997- July 2012 and distributed between January 1997- September 2018 in the USA. GE Healthcare Millennium Nuclear Medicine Systems Millennium MG, Millennium MC, and Millennium MYOSIGHT with Model/Item Numbers: NMH817, NMH816, NMH815, NMH814, NMH803, NMH802, NMH801, NMH800, NGS014, NGS012, NGS009, NGS005, NG00 have been recalled. The FDA has identified this as a Class I recall, the most serious type of recall and has said that the use of these devices may cause serious injuries or death.
How this recall would affect about 5000 Nuclear Medical Systems manufactured and sold by GE worldwide is not yet clear.
GE Healthcare has said that the incident that triggered this recall was caused by an improperly functioning primary motion stopper and a missing mechanical stopper which would limit the detector’s travel beyond its limits during normal operation.
GE Healthcare’s recalled Nuclear Medicine Systems are devices used to take images of a patient’s organs (for example, the heart, lungs, or brain) or tissues to help diagnose or treat a health condition or disease. These systems are intended for use as diagnostic imaging devices which allow the user to acquire data for high-resolution, three-dimensional images.
GE had sent a letter to its customers in US asking them to not use these imaging systems till it could complete a full and free inspection of all systems. The company said that it had completed the inspections of all systems in the US recently and had confirmed no related issues were found.