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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Nuclear Medicine systems are used for diagnostic imaging and treatment in healthcare settings. They help in detecting and monitoring various medical conditions through imaging techniques.
The risk arises from inadequate support for the detectors during transportation or relocation, which can compromise their mounting and potentially lead to a fall.
This recall is not part of a broader industry pattern.
The recall may necessitate immediate cessation of use for affected facilities, impacting patient care and leading to possible delays in medical imaging.
Serial numbers can typically be found on the back or bottom of the device. Refer to the user manual for specific locations.
Expect a refund or replacement to be processed within 4-8 weeks after the recall notification.
Keep copies of all receipts, notification letters, and any correspondence related to the recall for your records.
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.
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