China NMPA Product Recall - Digital X-ray fluoroscopy recording system

On November 7, 2017, Toshiba Medical Systems, Inc. initiated a voluntary global recall of its Digital X-ray Fluorography Systems, specifically the Ultimax-i DREX-UI80 model, affecting 538 units in China. This Level II recall, reported to the National Medical Products Administration (NMPA), addresses a critical firmware issue on the Allegro image processing board. The malfunction occurs when fluorescence imaging is deactivated just before single-shot acquisition, leading to an input switch bus anomaly. This prevents acquired images from being properly saved to the hard drive, posing a risk to patient record completeness and diagnostic integrity. As a corrective action, Toshiba committed to modifying the firmware on the Allegro boards within affected systems. This involves updating the system software on field-installed units to enable the necessary firmware modification. Furthermore, the company is implementing broader improvements to its design process, focusing on enhanced investigation and risk analysis protocols. Toshiba is also actively collaborating with its equipment suppliers to identify and resolve underlying asynchronous processing and timing-related problems on the Allegro board to prevent similar issues in the future. The recall affects regions including China, USA, Japan, South Korea, Singapore, and Spain.