GE HealthCare recalled 205 dual-head nuclear medicine gamma cameras on September 12, 2025. The recall affects models that may have been relocated without proper detector support, leading to potential falls. This issue 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 includes all serial numbers of the Sopha Medical Vision (SMV) DSXi/DST-XLi, DST-XL, and DSTi models. These devices were distributed worldwide.
The gamma cameras may have been transported without adequate detector support, risking excessive stress on the mounting mechanisms. This could lead to the detector falling.
No specific incidents have been reported as of now, but the potential for life-threatening injury exists due to the described hazard.
Healthcare providers and patients should stop using the devices immediately. They should follow recall instructions provided by GE HealthCare and contact their healthcare provider.
For additional information, contact GE Medical Systems Israel, Functional Imaging. Refer to the official recall notice for details.
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