China NMPA Product Recall - Digital medical X-ray imaging system

Shanghai Siemens Healthineers Co., Ltd. has initiated a voluntary recall of specific Digital Medical X-ray Imaging Systems, as reported by the National Medical Products Administration (NMPA) on September 29, 2016. The recall, detailed in a report dated August 2, 2016, addresses a critical manufacturing defect: the omission of a limit ring from a bed component on affected units. This oversight presents a significant safety concern, as it could potentially lead to patients slipping off the examination bed during use. The recall involves eight units, specifically Multix Fusion New Tianlong and Multix Fusion Yilong models, all distributed within China. This regulatory action falls under the purview of the NMPA and the Shanghai Food and Drug Administration. In response, Shanghai Siemens Healthineers has outlined a three-pronged corrective strategy. This includes sending safety advisory notices to all customers with potentially affected products, dispatching service engineers for on-site inspection of each of the eight units to confirm the missing component, and subsequently implementing appropriate corrective measures to resolve the safety issue once confirmed.