Health Canada — Medical Devices · Canada · 2012-12-10 · Type II
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Reported risk: In case of an unlikely failure of a brake, the C-Arm of the system may descend on the patient or operator. The risk of a failure of the brake and the associated potential hazard for patients or operators is specific for the stated software versions (VC14, VC20 or VC21) in conjunction with a specific configuration for the Artis Zeego system.
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