# China NMPA Product Recall - Angiography system

Source: https://www.globalkeysolutions.net/records/china_product_recall/toshiba-medical-systems-ltd/646cd97c-c764-4299-aa29-02c70a0bede8/
Source feed: China

> China NMPA product recall for Angiography system by Toshiba Medical Systems, Ltd. published June 14, 2017. Recall level: Level 2 Recall. On June 14, 2017, the National Medical Products Administration (NMPA) published details of a volunta

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Toshiba Medical Systems, Inc. voluntarily recalls angiography systems.
- Company Name: Toshiba Medical Systems, Ltd.
- Publication Date: 2017-06-14
- Product Name: Angiography system
- Recall Level: Level 2 Recall
- Recall Reason: The peak skin dose (PSD) value displayed by the dose tracking system (DTS) is greater than the DTS expected value. The DTS is an optional component of the XIDF-AWS801.
- Discovering Company: Toshiba Medical Systems (China) Co., Ltd.
- Manufacturing Company: Toshiba Medical Systems, Ltd.
- Summary: On June 14, 2017, the National Medical Products Administration (NMPA) published details of a voluntary recall initiated by Toshiba Medical Systems, Inc. pertaining to its angiography systems, specifically models INFX-9000V and INFX-9000C. The recall, formally reported by Toshiba Medical Systems (China) Co., Ltd. on June 5, 2017, stemmed from a critical issue where the Dose Tracking System (DTS), an optional component of the XIDF-AWS801, displayed peak skin dose (PSD) values higher than anticipated. This inaccuracy presented a potential patient safety risk concerning radiation exposure monitoring during medical procedures.

Operating under the NMPA's regulatory oversight, the affected products, registered with CFDA (Imported) 2014 No. 3302978 and No. 3302980, had been distributed in several countries including China, Japan, the USA, and Singapore. Designated as a Level Two recall, the company is implementing corrective measures. These actions involve installing modified software to resolve the DTS discrepancy. Additionally, Toshiba service representatives will arrange appointments with affected facilities for the installation of new parts as they become available. This recall aims to ensure the accurate operation of the angiography systems and maintain patient safety standards.

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