Health Canada — Medical Devices · Canada · 2019-08-09 · 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. The acquisition workstation may become unresponsive to normal user interaction. If this happens, it may become difficult to release the patient from the system following standard workflow steps. In this case, the manual removal of the biopsy needle is needed. A safety advisory notice is released to provide steps to the operator on how to easily release patient and proceed with exam. Siemens is also providing a software solution to resolve the issue.
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