China NMPA Product Recall - Digital X-ray fluoroscopy system

Toshiba Medical Systems, Inc. initiated a Level II voluntary recall of its digital X-ray fluoroscopy systems, as reported to the National Medical Products Administration (NMPA) on November 7, 2017. The recall pertains to devices registered under National Medical Device Registration Certificates 20153301489 and 20153301490, affecting 538 units globally across China, USA, Japan, South Korea, Singapore, and Spain, with 44 units in China. The primary issue is a firmware malfunction on the Allegro image processing board. When fluorescence imaging is disabled just before a single-shot acquisition, an input switch bus malfunction occurs. This leads to an abnormality in the logic for writing data from the input cache to the PCI cache, preventing acquired images from being saved to the hard drive. Under the NMPA's medical device regulatory framework, Toshiba Medical Systems (China) Co., Ltd. is undertaking corrective actions. These include updating the system software of installed devices to allow for a necessary firmware modification on the Allegro board. Toshiba and its supplier are also actively investigating and implementing solutions to identify and resolve asynchronous processing and timing-related issues affecting the Allegro board's control signals, aiming to prevent similar critical data loss in the future.