China NMPA Product Recall - X-ray imaging system

Beijing Shimadzu Medical Devices Co., Ltd., under the oversight of the National Medical Products Administration (NMPA), initiated a Class III voluntary recall for its X-ray Imaging Systems (Model: RAD SPEED M, CFDA (Approval) No. 20083301062). This recall, announced on August 2, 2017, stemmed from a report submitted on July 31, 2017. The core issue involves the X-ray tube support component, manufactured by Shimadzu Corporation of Japan, which has an expected service life of 10 years. If the equipment is used beyond this period or under abnormal conditions, a small number of units may develop cracks in the CH-200 section of the X-ray tube support. The primary concern is that these cracks could enlarge, potentially leading to the breakage of the support shaft and subsequent tilting of the X-ray tube support part. Fortunately, no malfunctions or injuries related to this defect have been reported within China. To address the issue, Beijing Shimadzu Medical Devices Co., Ltd. dispatched written communications to affected customers, informing them of the incident and reinforcing the importance of adhering to operational manuals. Furthermore, all five affected units in China are undergoing repair at their installation locations, which includes fitting additional protective parts to reinforce the X-ray tube support shaft. These corrective actions are projected to be completed within two months of the report date.