GE HealthCare recalled three Nuclear Medicine systems on December 10, 2025. The recall follows concerns over inadequate detector support, which could lead to a fall and serious injury. No incidents have been reported to date.
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 affects three units of the Nuclear Medicine systems from GE HealthCare. These systems have not been manufactured for several years and were distributed across the US, Brazil, Egypt, Canada, Mexico, Turkey, Italy, Sweden, Switzerland, France, Spain, Chile, Germany, Iran, and Greece.
Certain Nuclear Medicine systems may have been relocated without proper detector support. This could stress the detector mounting mechanisms, potentially causing the detectors to fall and lead to life-threatening injuries.
There have been no reports of detector falls or injuries related to this issue. The recall is classified as Class II, indicating a potential for serious injury.
Stop using the affected systems immediately. Contact GE Medical Systems Israel or your healthcare provider for further instructions.
For more information, call GE Medical Systems Israel. Visit the FDA's recall page for further details.
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