# China NMPA Product Recall - X-ray imaging system

Source: https://www.globalkeysolutions.net/records/china_product_recall/toshiba-medical-systems-ltd/ec8b1915-73fa-45eb-9271-626160d8e7a2/
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. 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 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 its X-ray Imaging Systems, as reported by the National Medical Products Administration (NMPA) on September 26, 2017. The recall was prompted by a critical defect identified in the internal program code structure responsible for image processing and storage, which could lead to the image processor locking up. This issue affects specific models including MARD-D25S RADREX-i, MARD-D80S RADREX-i, and MRAD-25S RADREX-i, which are clinically used for X-ray imaging examinations. The regulatory framework guiding this action is overseen by the NMPA, referencing CFDA (Imported) registration numbers 2011 No. 3304170 and 2010 No. 3302566. The affected products were distributed in regions including Japan and China, with 15 units sold in China. To address the identified software flaw, Toshiba Medical Systems is implementing a corrective action involving the deployment of a software patch for the image processor. This measure is intended to resolve the defect and ensure the safe and reliable operation of the affected X-ray imaging systems, maintaining patient safety and diagnostic accuracy.

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