GE HealthCare recalled 292 nuclear medicine gamma cameras on September 12, 2025. The devices may have been relocated without proper support, risking detector falls. This poses a serious risk of life-threatening injuries.
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
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The recall involves the Millenium MPR nuclear medicine gamma camera. All serial numbers in distribution are affected. The systems were distributed worldwide.
The affected gamma cameras may have been transported or relocated without adequate detector support. This can lead to excessive stress on the detector mounting mechanisms, increasing the risk of a detector fall.
There are no reported incidents or injuries at this time, but the potential for life-threatening bodily injury exists.
Patients and healthcare providers must stop using this device immediately. Follow the recall instructions provided by GE HealthCare and contact your healthcare provider for guidance.
For further assistance, contact GE Medical Systems Israel, Functional Imaging. Visit the FDA website for more details.
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