# China NMPA Product Recall - X-ray imaging system

Source: https://www.globalkeysolutions.net/records/china_product_recall/toshiba-medical-systems-ltd/8bf43da0-4b48-4805-8f4b-c6ce3418e3c6/
Source feed: China

> China NMPA product recall for X-ray imaging system by Toshiba Medical Systems, Ltd. published September 26, 2017. Recall level: Level 2 Recall. Toshiba Medical Systems, Inc., in collaboration with Toshiba Medical Systems (China) Co., Ltd., init

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Toshiba Medical Systems, Inc. voluntarily recalls X-ray imaging systems.
- Company Name: Toshiba Medical Systems, Ltd.
- Publication Date: 2017-09-26
- Product Name: X-ray imaging system
- Recall Level: Level 2 Recall
- Recall Reason: A defect in the internal program code structure related to image processing and storage caused the image processor to lock up.
- Discovering Company: Toshiba Medical Systems (China) Co., Ltd.
- Manufacturing Company: Toshiba Medical Systems, Ltd.
- Summary: Toshiba Medical Systems, Inc., in collaboration with Toshiba Medical Systems (China) Co., Ltd., initiated a voluntary Class II recall of specific X-ray imaging systems, including models such as MARD-D25S RADREX-i and MARD-D80S RADREX-i. The National Medical Products Administration (NMPA) of China publicly announced this recall on September 26, 2017. The primary issue identified was a critical defect in the internal program code structure related to image processing and storage, which caused the image processor to lock up unexpectedly during operation. These affected products were distributed in both Japan and China. To rectify this technical malfunction, Toshiba Medical Systems implemented a corrective action involving the distribution and application of a software patch specifically designed to restore the image processor's proper functionality. This measure aimed to prevent further lock-ups and ensure the consistent and safe performance of the X-ray imaging systems, underscoring the necessity for stringent software quality in medical devices under regulatory oversight.

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