WAUKESHA, WI - 6 November 2018 - On September 10, 2018, GE Healthcare was made aware of an incident at a hospital in the United States involving a Millennium MG Nuclear Medicine system in which the top detector detached and fell onto the detector below it. No patient was involved, and no one was injured as a result of the incident.
GE Healthcare responded immediately and worked with the facility to complete a thorough investigation. GE Healthcare has determined that the cause of this incident was that a mechanical stopper that limits detector travel was not present and, in addition, another primary motion stopper did not operate properly.
In a communication to customers dated September 14, 2018, GE Healthcare recommended that all relevant sites cease use of Millennium MG, Millennium MC, and Millennium MYOSIGHT Nuclear Medicine systems until the company could complete a full and free inspection of all systems.
GE Healthcare has completed inspections on all Millennium MG, Millennium MC and Millennium MYOSIGHT Systems, and has confirmed no related issues in all global systems.
The U.S. Food and Drug Administration (FDA) has recently classified this recall as a Class I recall.
Maintaining a high level of safety and quality is GE Healthcare’s highest priority.
Customers needing additional information regarding this field action may contact GE Healthcare Customer Service at 1-800-345-2700.