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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Nuclear Medicine systems are used for diagnostic imaging, allowing healthcare providers to visualize organ function and structure. These systems are critical in various medical settings, particularly in oncology and cardiology.
The hazard arises from improper support during transport, which can lead to excessive stress on the detector mounting mechanisms. This could result in the detector falling, posing a serious injury risk to patients and healthcare staff.
This recall is not part of a broader industry pattern.
The recall necessitates immediate action from healthcare providers to prevent potential injuries, impacting patient care and safety protocols.
The model and serial numbers can usually be found on the back or side of the device, or in the user manual.
Expect a response time of 4-6 weeks for follow-up instructions or refund processing.
Keep a record of all correspondence related to the recall, including dates, times, and the names of individuals you spoke with.
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.
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