Health Canada — Medical Devices · Canada · 2020-06-05 · Type II
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Reported risk: Siemens Healthineers has become aware of an error that can occur when performing a biopsy using the inspect function. If an examination is interrupted when the inspect projection view (pv) is active and a vacuum biopsy system is being used, the tube arm can only be moved to a ±6° position by using the rotation buttons instead of the ±15° position that is possible with other projection views. A safetycustomer advisory notice will provide steps to the operator on how to diactivate the inspect functionality
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