GE HealthCare recalled 45 dual-head nuclear medicine gamma cameras on September 12, 2025. The recall affects devices that may have been relocated without proper support, risking a detector fall. This defect can lead to 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 Elscint SPX4 nuclear medicine gamma camera. These devices were distributed worldwide.
The gamma cameras may have been transported without adequate detector support. This can stress the mounting mechanisms, risking a fall of the detector and potentially causing severe injuries.
No specific incidents have been reported yet, but the hazard poses a high risk of life-threatening injury.
Stop using the gamma camera immediately. Follow the recall instructions provided by GE HealthCare and contact your healthcare provider.
For more information, contact GE Medical Systems Israel, Functional Imaging. Visit the FDA recall webpage for updates.
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