GE HealthCare recalled 205 SMV DSXi dual-head nuclear medicine gamma cameras used for cardiac imaging distributed worldwide. The recall cites potential detector mounting stress after End of Guaranteed Service. Hospitals should stop using these devices and follow the manufacturer’s recall instructions. Contact GE Medical Systems Israel Functional Imaging or a healthcare provider for guidance.
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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Dual-head nuclear medicine gamma cameras from SMV are used for cardiac imaging in medical facilities. They help image cardiac blood flow and function.
If the detector mounting is compromised due to inadequate support during transport or relocation after service ends, the detector could detach or fall, risking serious injury.
This recall is not described as part of a broader industry pattern in the provided data.
Hospitals must avoid using affected cameras until cleared. The recall could affect patient safety and imaging workflow, with potential procurement delays.
Refer to the FDA recall page linked in the notice and GE HealthCare communications for model numbers and serial ranges.
Recalls typically require vendor-provided service or replacement steps; exact timelines are not stated in the release.
Maintain copies of recall notices, service correspondence, and any replacement agreements.
Models: DSXi, DST-XLi, DST-XL, DSTi. Distribution: Worldwide. Quantity: 205 units. Sold: Unknown. Price: Unknown.
No injuries or incidents have been reported.
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