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

Source: https://www.globalkeysolutions.net/records/china_product_recall/toshiba-medical-systems-ltd/d466a3d5-8436-4351-8467-6f3b8cd56d65/
Source feed: China

> China NMPA product recall for Digital X-ray fluoroscopy system by Toshiba Medical Systems, Ltd. published November 09, 2017. Recall level: Level 2. Toshiba Medical Systems, Inc. initiated a Level II voluntary recall of its digital X-ray fluoroscopy

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Toshiba Medical Systems, Inc. is voluntarily recalling its digital X-ray imaging systems.
- Company Name: Toshiba Medical Systems, Ltd.
- Publication Date: 2017-11-09
- Product Name: Digital X-ray fluoroscopy system
- Recall Level: Level 2
- Recall Reason: The following firmware issue occurred on the Allegro board (image processing board) of the image processing equipment. When fluorescence photography was turned off just before single-shot acquisition, the input buffer storage switch malfunctioned, causing an anomaly in the logic for timing the writing from the input buffer to the PCI cache. As a result, the acquired image was not saved to the hard drive.
- Discovering Company: Toshiba Medical Systems (China) Co., Ltd.
- Manufacturing Company: Toshiba Medical Systems, Ltd.
- Summary: 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.

Company: https://www.globalkeysolutions.net/companies/toshiba-medical-systems-ltd/2aaf56fb-b20d-412a-967a-c18cd133e252/