China NMPA Product Recall - Whole-body X-ray computed tomography spiral scanning device

Shanghai Siemens Medical Devices Co., Ltd. initiated a Level 3 voluntary recall on June 2, 2015, under the oversight of the National Medical Products Administration (NMPA), for its whole-body X-ray computed tomography spiral scanning devices, specifically the SOMATOM Emotion 6-slice and 16-slice configurations. The recall was prompted by the discovery of fatigue fracture in the bolts securing the balance block. This critical issue caused the balance block to loosen, collide with adjacent components, and generate noise. While no injuries were reported, the company identified a severe potential risk where undetected, complete bolt failure could lead to the balance block detaching and potentially injuring patients or equipment operators. An investigation by Shanghai Siemens Medical Devices Co., Ltd. traced the root cause to a flawed bolt manufacturing process design and deviations between raw materials and specified drawing requirements. In response, the company is issuing safety advisory notices to affected customers, detailing the risks and outlining the final corrective solution. This includes activating an on-site service for balance block bolt remediation. The recall impacts 214 products globally, with 41 units sold in China.