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 System (Model RAD SPEED M, Registration No.: CFDA (Approval) No. 20083301062), as reported to the National Medical Products Administration (NMPA) on July 31, 2017. The recall, published on August 2, 2017, addresses a structural integrity concern with the X-ray tube support component (CH-200 part). This part, imported from Shimadzu Corporation of Japan, has an expected service life of 10 years. Prolonged use beyond this period, or abnormal operation, can lead to the development of cracks in the support shaft. If these cracks widen, they pose a risk of the shaft breaking, causing the X-ray tube support to tilt. Although no related malfunctions or injuries have been reported within China, the company is taking proactive measures. Beijing Shimadzu Medical Devices Co., Ltd. has informed affected customers via written letters, emphasizing adherence to operational manuals. Furthermore, all five identified affected units (batch numbers 61C995, 61C996, 61C997, 61C998, 61C999) are undergoing corrective action. This involves fitting additional protective components to reinforce the X-ray tube support shaft. Repairs are being conducted at the installation sites and are projected to be completed within two months. This action aligns with the company's commitment to product safety and regulatory compliance.