GE HealthCare recalled 1,386 nuclear medicine gamma cameras on September 12, 2025. Certain models may have been relocated without proper support, risking detector integrity. This could lead to life-threatening injuries from falls.
GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING or your healthcare provider for instructions. Notification method: Letter
The recall includes all serial numbers of the Millenium MG/MC nuclear medicine gamma camera. These cameras were distributed worldwide.
Improper relocation of the gamma cameras may cause excessive stress on the detector mounting mechanisms. This can result in a detector fall, posing a high risk of life-threatening injuries.
There are no reported incidents or injuries related to this recall at this time. The potential for serious injuries exists due to the nature of the hazard.
Immediately stop using the device. Follow the manufacturer’s recall instructions and contact GE Medical Systems Israel or your healthcare provider for guidance.
For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0297-2026.
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