China NMPA Product Recall - Angiography system

Toshiba Medical Systems, Inc., with its agent Toshiba Medical Systems (China) Co., Ltd., initiated a voluntary Level Two recall of specific angiography systems, including models INFX-9000V and INFX-9000C. This action, reported to the National Medical Products Administration (NMPA) on June 5, 2017, and subsequently published on June 14, 2017, addresses a significant issue concerning the Dose Tracking System (DTS). The DTS, an optional component of the XIDF-AWS801, was found to display a Peak Skin Dose (PSD) value greater than its expected value, indicating an inaccuracy in dose reporting during angiography examinations and interventional treatments. This recall is conducted under the NMPA's regulatory framework, affecting products distributed in China, Japan, USA, and Singapore. As corrective action, Toshiba will install modified software to rectify the problem and, once new parts are available, a service representative will schedule appointments to install these components on the affected systems, ensuring accurate dose measurement and patient safety.