Siemens Medical Solutions USA, Inc recalls Uroskop Omnia max, Model No. 10762473 - Product Usage: Urosk
Recalled Product
Uroskop Omnia max, Model No. 10762473 - Product Usage: Uroskop Omnia Max is a device intended to visualize anatomical structures by converting an Xray pattern into a visible image. The system is designed primarily for urological diagnosis and the support of urological therapeutic applications such as examinations and small interventions of the urogenital tract.
Hazard / Issue
Siemens became aware of an issue of incorrect use of the bypass key overriding the built-in collision control creating risk of collision with obstacles or persons when the operator uses the override function.
Issued by
FDA
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