GE HealthCare recalled 28 dual-head gamma cameras on September 12, 2025. The recall comes after concerns that inadequate support during relocation could lead to a detector fall. This situation poses a high risk of life-threatening injury.
GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service 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.
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: Letter
The recall affects the Elscint SPX6 nuclear medicine gamma camera designed for cardiac imaging. All serial numbers in distribution are included in the recall. These devices were distributed worldwide.
Inadequate detector support during transport can stress mounting mechanisms. This can cause the detectors to fall, posing a high risk of serious bodily injury.
No specific incidents have been reported as of yet, but the potential for life-threatening injuries exists due to the described hazard.
Stop using the device immediately. Follow the recall instructions from GE HealthCare and contact your healthcare provider for guidance.
For assistance, contact GE Medical Systems Israel, Functional Imaging. More information is available at the FDA recall webpage.
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