GE HealthCare recalls 64 Elscint Model 4XX dual-head gamma cameras used for cardiac imaging worldwide after discovering potential detector mounting failure during transport. A detector fall could cause life-threatening injuries. Hospitals should stop using the device and follow the manufacturer’s recall instructions.
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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Nuclear medicine gamma cameras are used for specialized cardiac imaging to visualize physiological processes.
If a unit is moved without proper support, the detector mounting can experience excessive stress, risking detector detachment and potential fall.
This recall is not described as part of a broader industry pattern in the provided information.
Hospitals may need to halt imaging procedures using affected cameras. Patient care workflows could be disrupted while units are evaluated or replaced.
Recall notices and FDA enforcement listing are available at the provided FDA enforcement link (Z-0291-2026).
Timeline for remediation is not specified by the recall.
Keep recall notice, serial/model identifiers, transport records, and all correspondence as part of the device’s risk management file.
• Product: Elscint Model 4XX dual-head gamma camera • Brand: GE HealthCare • Units recalled: 64 • Distribution: Worldwide • Serial numbers: All serial numbers in distribution • Manufacturer: GE Medical Systems Israel, Functional Imaging • Recall date: 2025-09-12 • Remedy: Stop using the device and follow recall instructions • Status: Active
No injuries or incidents have been reported.
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