# China NMPA Product Recall - Interventional imaging systems equipped with the recall-affected gantry motion control board (MCB)

Source: https://www.globalkeysolutions.net/records/china_product_recall/ge-medical-systems-scs/510ed6ba-12c0-4553-a69a-2d4cc0a4d027/
Source feed: China

> China NMPA product recall for Interventional imaging systems equipped with the recall-affected gantry motion control board (MCB) by GE Medical Systems SCS published June 03, 2015. Recall level: Level 3 Recall. GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. initiated a voluntary Level 3 recall 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. is voluntarily recalling interventional imaging systems equipped with gantry motion control boards.
- Company Name: GE Medical Systems SCS
- Publication Date: 2015-06-03
- Product Name: Interventional imaging systems equipped with the recall-affected gantry motion control board (MCB)
- Recall Level: Level 3 Recall
- Recall Reason: Affected interventional imaging systems may stop gantry movement due to gantry motion control board (MCB) failure. Restricted gantry movement may affect or prolong interventional procedures. Diagnostic and image-guided performance may be impaired. After resetting, the equipment can continue to be used, and manual controls for the gantry and bed are also available. There have been no reports of injuries caused by this issue.
- Discovering Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Manufacturing Company: GE Medical Systems SCS
- Summary: GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. initiated a voluntary Level 3 recall on June 3, 2015, under the oversight of the National Medical Products Administration (NMPA) of China. The recall addresses a critical issue affecting several interventional imaging systems, including the INNOVA 3100, INNOVA 3100-IQ, Innova IGS 530, and Innova IGS 630 models. The primary concern stems from a failure of the gantry motion control board (MCB), which can cause the gantry to stop moving. While systems can be reset and manual controls remain functional, and no personnel injuries have been reported, this malfunction has the potential to prolong interventional procedures and impair diagnostic and image guidance performance. In response, GE Healthcare implemented two key corrective actions. The company communicated directly with affected customers via email, providing essential guidance for safe system operation. Additionally, GE Healthcare dispatched engineers to customer sites to perform necessary free corrections on all impacted products. This recall extends to multiple global regions, including China, the United States, the European Economic Area, and Canada.

Company: https://www.globalkeysolutions.net/companies/ge-medical-systems-scs/7eda2422-02cb-413a-8d7d-411a779dd49c/