GE Medical Systems Israel is recalling approximately 1,843 nuclear medicine imaging systems, including the Infinia and Millennium VG model lines. The recall was initiated because the systems may have an incorrect version of gantry software installed, which can cause the detector to move unexpectedly in a radial direction. This unintended motion can occur while a patient is being positioned or during an active medical scan. GE is contacting affected facilities to perform necessary software updates.
If the detector moves unexpectedly, it could strike a patient or medical staff, potentially resulting in life-threatening crush injuries or other physical trauma. No specific injuries have been mentioned in the recall notice, but the defect poses a severe safety risk during diagnostic procedures.
Correction or repair of software.
Recalled quantity: 1822 units.
Recalled quantity: 21 units.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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