China NMPA Product Recall - Digital X-ray fluoroscopy system

Toshiba Medical Systems, Inc., through its agent Toshiba Medical Systems (China) Co., Ltd., initiated a Level II voluntary recall of its digital X-ray fluoroscopy system (NMPA Registration Nos. 20153301489, 20153301490) as reported on November 7, 2017, and published by the National Medical Products Administration (NMPA) on November 9, 2017. The recall addresses a critical firmware issue on the Allegro image processing board. The malfunction occurs when fluorescence imaging is deactivated just prior to single-shot acquisition, causing an input switch bus anomaly. This prevents acquired images from being correctly saved to the hard drive. To rectify this, Toshiba has committed to modifying the Allegro board's firmware and updating the system software on all affected field-installed units. The company is also implementing broader corrective actions, including enhancements to their design process for investigating and performing risk analysis. Collaboration with the equipment supplier is underway to identify and resolve asynchronous processing and timing-related issues affecting control signals on the Allegro board. The recall impacts 44 units in China and extends globally to countries including the USA, Japan, South Korea, Singapore, and Spain.