GE HealthCare Israel, Functional Imaging recalled 3 Elscint Helix dual-head gamma cameras worldwide. If moved without adequate detector support, mounting stress could cause a detector fall and life-threatening injury. Hospitals should stop using the device immediately and contact GE Medical Systems Israel, Functional Imaging for 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 Helix is a dual-head gamma camera used for cardiac imaging in nuclear medicine. Hospitals rely on such devices for accurate diagnostic imaging.
If relocated without adequate detector support after End of Guaranteed Service, the detector mounting can suffer excessive stress, risking detachment or falling of the detector.
This recall is not described as part of a broader industry pattern in the notice.
Hospitals must stop using the devices immediately. The recall affects three units worldwide, with potential imaging workflow disruptions until remedies are implemented and devices are replaced or repaired.
Recall notice and manufacturer instructions provided by GE Healthcare Israel Functional Imaging. FDA recall page may have additional details.
Remedy timeline is not specified in the notice. Actions depend on manufacturer coordination with healthcare facilities.
Keep the recall letter, correspondent communications, service reports, and replacement or repair receipts for records.
Product: Elscint Helix dual-head nuclear medicine gamma camera Serial numbers: All serial numbers in distribution Where sold: Worldwide distribution When sold: Unknown Price: Unknown
No injuries or incidents have been reported.
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