GE HealthCare recalled three units of the Elscint Helix nuclear medicine gamma camera on September 12, 2025. The recall affects systems that may have been transported without proper support, risking detector falls. This issue poses a high risk of life-threatening injuries.
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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This recall involves the Elscint Helix dual-head nuclear medicine gamma camera. All serial numbers in distribution are affected. The devices were distributed worldwide.
The detectors in these cameras may fall if the mounting mechanisms are compromised due to inadequate support during transport. This situation poses a high risk of life-threatening bodily injury.
GE HealthCare has not reported any specific injuries associated with this recall. The potential for life-threatening injuries exists if the detectors fall.
Stop using the Elscint Helix nuclear medicine gamma camera immediately. Follow the instructions provided by GE HealthCare. Contact GE Medical Systems Israel or your healthcare provider for further instructions.
For more information, visit the GE HealthCare website or call GE Medical Systems Israel directly. Additional details can be found at the FDA recall notice.
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