China NMPA Product Recall - Angiography system

On June 14, 2017, the National Medical Products Administration (NMPA) published details of a voluntary recall initiated by Toshiba Medical Systems, Inc. pertaining to its angiography systems, specifically models INFX-9000V and INFX-9000C. The recall, formally reported by Toshiba Medical Systems (China) Co., Ltd. on June 5, 2017, stemmed from a critical issue where the Dose Tracking System (DTS), an optional component of the XIDF-AWS801, displayed peak skin dose (PSD) values higher than anticipated. This inaccuracy presented a potential patient safety risk concerning radiation exposure monitoring during medical procedures.

Operating under the NMPA's regulatory oversight, the affected products, registered with CFDA (Imported) 2014 No. 3302978 and No. 3302980, had been distributed in several countries including China, Japan, the USA, and Singapore. Designated as a Level Two recall, the company is implementing corrective measures. These actions involve installing modified software to resolve the DTS discrepancy. Additionally, Toshiba service representatives will arrange appointments with affected facilities for the installation of new parts as they become available. This recall aims to ensure the accurate operation of the angiography systems and maintain patient safety standards.