China NMPA Product Recall - Angiography system

Toshiba Medical Systems, Inc. initiated a voluntary Level Two recall in China, affecting its INFX-9000V and INFX-9000C angiography systems. This action, reported to the National Medical Products Administration (NMPA) and its provincial departments on June 5, 2017, addressed a critical issue where the dose tracking system (DTS) displayed peak skin dose (PSD) values greater than expected. The DTS, an optional component of the XIDF-AWS801, showed inaccuracies that could potentially misinform users about patient radiation exposure during angiography examinations and interventional treatments. The regulatory framework for this recall is established by the NMPA in China, ensuring compliance and patient safety. To rectify the problem, Toshiba Medical Systems (China) Co., Ltd. committed to installing modified software on all affected systems. This corrective action involves Toshiba service representatives scheduling appointments with customers for software updates. Post-recall measures include follow-up visits and continuous monitoring of system operation to ensure the problem is resolved and the systems function normally. The recall was estimated to be completed by June 30, 2017, aiming to restore accurate dose tracking capabilities and enhance patient safety.