GE HealthCare recalled 102 dual-head nuclear medicine gamma cameras on September 12, 2025. The recall stems from inadequate support during transportation that could lead to a detector fall, posing a life-threatening injury risk. The affected devices are past their End of Guaranteed Service and should not be used immediately.
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 involves all serial numbers of Starcam/Camstar nuclear medicine gamma cameras. These devices are intended for cardiac imaging. They were distributed worldwide.
Inadequate detector support during transportation can result in excessive stress on the mounting mechanisms. This may compromise their integrity and lead to a potential fall of the detector.
No specific incidents or injuries have been reported as of the recall date. However, the potential for life-threatening injury exists.
Stop using the gamma camera immediately. Contact GE Medical Systems Israel or your healthcare provider for further instructions and follow the recall process.
For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0303-2026.
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