GE HealthCare recalled 12 Nuclear Medicine systems on December 10, 2025, due to a potential fall hazard. The affected systems may have inadequate support during transport, risking detector integrity. No injuries have been reported, but the risk of life-threatening incidents exists.
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 12 Nuclear Medicine systems past their End of Guaranteed Service. These systems have not been manufactured for several years and are distributed in the U.S., Canada, and several other countries.
Improper transport may lead to excessive stress on the detector mounting mechanisms, increasing the risk of a detector fall. This presents a high risk of life-threatening bodily injury.
There have been no reports of falls or injuries associated with this issue thus far. The recall is proactive, addressing a potential hazard before it results in incidents.
Stop using the affected Nuclear Medicine systems immediately. Contact GE Medical Systems Israel or your healthcare provider for further instructions.
For more information, call GE Medical Systems Israel or visit the recall page on the FDA website at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1046-2026.
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