China NMPA Product Recall - X-ray imaging system

Beijing Shimadzu Medical Devices Co., Ltd. initiated a voluntary Class III recall for its X-ray Imaging Systems (model RAD SPEED M, CFDA Approval No. 20083301062), reported to the National Medical Products Administration (NMPA) on August 2, 2017. The recall addresses a potential issue with the X-ray tube support component, which has an expected service life of 10 years. The company identified that after this period or under abnormal use, the support part (CH-200 section) could develop cracks. If these cracks expand, they may lead to the breakage of the X-ray tube support shaft, causing the X-ray tube to tilt. This action aligns with a broader recall initiated by Shimadzu Corporation of Japan, the original supplier of the affected components. Although Beijing Shimadzu Medical Devices Co., Ltd. reported no incidents or injuries within China related to this issue, the company undertook immediate corrective measures. These included dispatching written notices to affected customers, advising adherence to operational manuals, and installing additional protective parts to reinforce the X-ray tube support shafts on the five identified units. Repairs are being conducted on-site at equipment installation locations, with an anticipated completion within two months of the recall report date, ensuring patient safety and product integrity under NMPA guidance.