GE HealthCare recalled 64 units of the Elscint Model 4XX gamma camera on September 12, 2025. The recall affects systems that lack adequate support during transport, risking detector falls. If the detectors fall, they can cause serious injuries to patients and healthcare providers.
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 Model 4XX, a dual-head nuclear medicine gamma camera. The affected units are all serial numbers distributed worldwide. The product is used specifically for cardiac imaging.
The gamma cameras may have been relocated without proper detector support. This can lead to excessive stress on the detector mounting mechanisms, compromising their integrity.
No specific incidents have been reported yet, but the risk of a detector fall poses a life-threatening danger.
Stop using the gamma camera immediately. Patients and healthcare providers should follow the manufacturer's recall instructions.
For further assistance, contact GE Medical Systems Israel, Functional Imaging, or your healthcare provider. More information is available at the FDA recall link.
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