China NMPA Product Recall - Angiography system

Toshiba Medical Systems, Inc., through its Chinese subsidiary Toshiba Medical Systems (China) Co., Ltd., initiated a voluntary Level Two recall of specific angiography systems. This action, reported to the National Medical Products Administration (NMPA) on June 5, 2017, involves models INFX-9000V and INFX-9000C. The primary issue identified is that the Dose Tracking System (DTS), an optional component of the XIDF-AWS801, displayed a Peak Skin Dose (PSD) value greater than its expected measurement, posing a potential concern for accurate radiation dose monitoring. The affected devices are designed for whole-body angiography examinations and interventional treatments, with two units specifically identified for sale in China. The recall affects products in China, Japan, USA, and Singapore. To rectify this, Toshiba is implementing corrective actions, which include installing modified software on the affected systems to correct the inaccurate PSD display. Additionally, a Toshiba service representative will schedule appointments for new part installations once they become available, ensuring the systems accurately report dose values and operate within specified parameters.