GE HealthCare recalled 11 Cardial nuclear medicine gamma cameras on September 12, 2025. The recall follows concerns over inadequate detector support potentially leading to life-threatening falls. The affected systems were transported without proper safeguards, compromising safety.
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 the Elscint Cardial nuclear medicine gamma camera, with all serial numbers in distribution affected. The systems are designed specifically for cardiac imaging and distributed worldwide.
The nuclear medicine systems may have been relocated without adequate support for the detectors. This can apply excessive stress on detector mounting mechanisms, risking a fall that could cause serious injury.
No specific incidents or injuries have been reported as of now. However, the potential for life-threatening injuries exists if the detectors fall.
Healthcare providers and patients must stop using the Cardial gamma cameras immediately. Follow the recall instructions from GE HealthCare or consult your healthcare provider.
For further instructions, contact GE Medical Systems Israel at the provided channels. More details can be found on the official FDA website.
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