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

Source: https://www.globalkeysolutions.net/records/china_product_recall/toshiba-medical-systems-ltd/0e9b3e3a-4a77-4feb-b0cf-e36290592f02/
Source feed: China

> China NMPA product recall for Digital X-ray fluoroscopy recording system by Toshiba Medical Systems, Ltd. published November 09, 2017. Recall level: Level 2. On November 7, 2017, Toshiba Medical Systems, Inc. initiated a voluntary global recall of its Digita

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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 recording 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: 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.

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