China NMPA Product Recall - X-ray computed tomography equipment, whole-body X-ray computed tomography spiral scanning device

Shanghai Siemens Medical Devices Co., Ltd. issued a voluntary Level III recall for several models of its X-ray Computed Tomography Equipment and Whole-Body X-ray Computed Tomography Spiral Scanning Devices. Reported on November 25, 2016, and published by the National Medical Products Administration (NMPA) on December 29, 2016, the recall addresses a critical product issue. The company discovered that the residual current device (RCD) in the power distribution cabinet of the affected products could be damaged. This defect poses a risk of equipment interruption during patient scanning, potentially delaying diagnosis or requiring a re-scan. The regulatory framework for this action falls under the NMPA (formerly CFDA), with a Level III classification indicating a low probability of adverse health consequences. To resolve the issue, Siemens committed to providing on-site safety notices to customers of the 18 affected products in China. These notices will detail the potential risks and the company's corrective plan. The required action involves replacing the potentially problematic parts to ensure the reliable and safe operation of the medical imaging devices, thereby mitigating patient inconvenience and upholding product safety standards.