Health Canada — Medical Devices · Canada · 2016-03-17 · Type II
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Reported risk: In the framework of the regular post market surveillance the following problems have been identified: A. In Artis zeego systems, angulations in the vicinity of the c-arm collision area can cause the cable inlet to become clamped and can result in mechanical damage. B. In Artis systems with A100Plus generators, an attempt to resume operation following detection of a fault (such as a short circuit in the x-ray tube) can result in the failure of a module in the high-voltage generator.
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