GE Healthcare recalled seven Nuclear Medicine systems on December 10, 2025, due to potential detector falls. The recall affects systems that have exceeded their End of Guaranteed Service. No injuries or falls have been reported.
GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affected Product Details section of this letter) 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. There have been no reports of detector falls or injuries as a result of this potential issue. The Impacted Systems affected by this notice are those that have not been manufactured for several years. GE HealthCare has previously communicated End of Guaranteed Service for these Impacted Systems.
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: Telephone
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The recall involves seven units of the Nuclear Medicine systems from GE Healthcare. These systems have not been manufactured for several years and are distributed in the U.S., Brazil, Egypt, Canada, Mexico, Turkey, Italy, Sweden, Switzerland, France, Spain, Chile, Germany, Iran, and Greece.
The affected systems may have been transported without adequate support for their detectors. This could lead to excessive stress on the mounting mechanisms, causing a potential fall of the detector.
No incidents or injuries have been reported related to this potential hazard. The recall was issued as a precaution due to the risk of a detector fall.
Stop using the affected systems immediately. Contact GE Healthcare or your healthcare provider for further instructions and to arrange for a remedy.
For more information, contact GE Medical Systems Israel, Functional Imaging, or visit the FDA recall website.
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