GE HealthCare recalled 82 units of the Millenium Myosight gamma camera on September 12, 2025. The recall affects systems that may lack sufficient support during transport, posing a risk of detector falls. This defect can result in 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 all serial numbers of the Millenium Myosight dual-head nuclear medicine gamma camera. These devices were distributed worldwide and are designed specifically for cardiac imaging.
The gamma camera may be transported without adequate support, leading to excessive stress on the detector mounting mechanisms. This condition can compromise the integrity of the detectors, potentially resulting in a fall.
No specific incidents have been reported yet, but the risk of life-threatening injuries exists if the detectors fall.
Stop using the device immediately. Follow the instructions provided in the recall notification and contact GE Medical Systems Israel or your healthcare provider for further guidance.
For assistance, contact GE Medical Systems Israel, Functional Imaging. Visit the FDA recall page for more details: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0298-2026.
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