China NMPA Product Recall - Digital X-ray fluoroscopy system

Toshiba Medical Systems, Inc., along with its agent Toshiba Medical Systems (China) Co., Ltd., initiated a voluntary Level II recall of its digital X-ray fluorography systems. This recall, reported to the National Medical Products Administration (NMPA) on November 7, 2017, addresses a significant firmware defect on the Allegro image processing board. The core issue arises when fluorescence imaging is deactivated just before a single-shot acquisition, causing a malfunction in the input switch bus. This leads to an abnormality in the logic for transferring data from the input cache to the PCI cache, ultimately preventing acquired images from being saved to the hard drive. The affected product, specifically the Ultimax-i DREX-UI80 model, impacted 538 units worldwide, with 44 in China, across regions including China, USA, Japan, South Korea, Singapore, and Spain. Required corrective actions include modifying the Allegro board's firmware and updating the system software of all installed units to implement these changes. Furthermore, Toshiba and its suppliers are reviewing and enhancing design processes for risk analysis to proactively identify and resolve future asynchronous processing and timing-related issues.