China NMPA Product Recall - Medical angiography X-ray machine

On December 17, 2020, Siemens Healthineers initiated a voluntary Class II recall for several models of its medical angiography X-ray machines. This action was reported by the Shanghai Municipal Drug Administration under the regulatory framework of the National Medical Products Administration (NMPA). The recall addresses a potential issue found in a small number of Artis machines, specifically those equipped with Siemens Tilt/Step (OR) examination beds and running software version VD11E. The main violation or issue centers on the safety limit switch, which was found to be in a default activated state prematurely, before the examination bed reached its destination. A malfunction in this switch could obstruct or restrict the examination bed's movement, causing the system to execute a safety stop. Should this occur, a field service engineer would be required to reactivate the system. Siemens Healthineers' required action is this voluntary recall to mitigate the identified safety risk. Detailed information regarding affected product models, specifications, and batches is provided in an associated "Medical Device Recall Event Report Form."