GE Medical Systems Israel is recalling 45 units of the Elscint SPX4 dual-head gamma camera worldwide. The recall cites a risk from transporting or relocating systems past End of Guaranteed Service without adequate detector support. Hospitals and clinics should stop using the device immediately and follow manufacturer 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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The Elscint SPX4 is a dual-head nuclear medicine gamma camera used for cardiac imaging. Hospitals rely on these devices for functional imaging and diagnosis. The recall concerns post-service transport that may damage detector mounting components.
If the detector mounting is stressed during transport or relocation without proper support, mounting integrity can fail. A detector fall could occur, potentially causing life-threatening injuries.
This recall is not indicated as part of a broader industry pattern at this time.
Hospitals could face urgent service interruptions or equipment replacement needs. The recall affects 45 units worldwide and may require on-site servicing or replacement to ensure patient safety.
Refer to GE Medical Systems Israel Functional Imaging and the FDA recall page.
Recall actions and replacement timelines will be issued by GE Medical Systems Israel; no specific window is stated in the notice.
Keep copies of all recall notices, communications with the manufacturer, service reports, and any equipment relocation records.
Model: Elscint SPX4. Distribution: Worldwide. Units recalled: 45. Serial numbers: All serial numbers in distribution. Sold at: Worldwide distribution. When sold: Not specified. Price: Unknown.
No injuries or incidents have been reported in connection with this recall.
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