Siemens Medical Solutions USA, Inc recalls ARTIS Pheno, Fluoroscopic X-Ray system, Model Number 1084900
Recalled Product
ARTIS Pheno, Fluoroscopic X-Ray system, Model Number 10849000
Hazard / Issue
During manual LAO/RAO rotation at maximum speed or a combination of LAO/RAO and Cran/Caud rotation at maximum speed, the possibility exists for the safety monitoring within the system control to become activated. As a result, the C-arm stops the rotation and can drop up to 40 mm (1.6 ).
Issued by
FDA
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