GE HealthCare recalled 38 Nuclear Medicine systems on December 10, 2025, due to potential detector falls. The affected systems may have been relocated without adequate support, risking serious injury. No incidents have been reported, but the recall is classified as a Class II hazard.
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 38 units of Nuclear Medicine systems from GE HealthCare. These systems are past their End of Guaranteed Service and have been distributed in the US, Canada, Brazil, and several European countries.
Transporting these systems without proper detector support can stress the mounting mechanisms. This stress can compromise their integrity, leading to a potential detector fall.
There have been no reported falls or injuries linked to this issue. The potential risk for serious bodily injury remains.
Stop using the systems immediately. Contact GE MEDICAL SYSTEMS ISRAEL or your healthcare provider for further instructions.
For more information, call GE HealthCare at their designated customer service number. Visit the FDA link for additional details.
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