China NMPA Product Recall - X-ray imaging system

On September 26, 2017, Toshiba Medical Systems, Inc. initiated a voluntary Class II recall of specific X-ray imaging systems in response to a critical software defect. The recall, reported by Toshiba Medical Systems (China) Co., Ltd. to the National Medical Products Administration (NMPA), specifically involved models registered under CFDA (Imported) 2011 No. 3304170 and CFDA (Imported) 2010 No. 3302566. The primary issue identified was a flaw in the internal program code structure responsible for image processing and storage, which could lead to the image processor locking up during operation. This malfunction posed a risk to the reliability of diagnostic imaging. The affected products included MARD-D25S RADREX-i, MARD-D80S RADREX-i, and MRAD-25S RADREX-i systems, with 15 units distributed in China. Under the NMPA's regulatory oversight, the required corrective action involves the application of a software patch designed to rectify the image processor defect. This action aims to restore the full functionality and safety of the recalled X-ray imaging systems, ensuring their reliable performance in clinical use across affected regions, including Japan and China.