# China NMPA Product Recall - Medical angiography X-ray machine

Source: https://www.globalkeysolutions.net/records/china_product_recall/ge-medical-systems-scs/b53e264d-27c7-4d30-b3b8-5e3be11c72dd/
Source feed: China

> China NMPA product recall for Medical angiography X-ray machine by GE Medical Systems SCS published December 19, 2013. Recall level: . The National Medical Products Administration (NMPA) issued a recall notice on December 19, 2013, reg

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: GE Medical Systems SCS recalls medical angiography X-ray machines
- Company Name: GE Medical Systems SCS
- Publication Date: 2013-12-19
- Product Name: Medical angiography X-ray machine
- Recall Reason: When performing fluoroscopy on a dual-C cardiovascular machine, if the fluoroscopy foot switch is released while changing the lateral view, there is a potential malfunction that could result in loss of X-ray imaging, system lock-up, and a restart required to continue the examination. No injuries have been reported due to this malfunction.
- Discovering Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Manufacturing Company: GE Medical Systems SCS
- Summary: The National Medical Products Administration (NMPA) issued a recall notice on December 19, 2013, regarding medical angiography X-ray machines manufactured by GE Medical Systems SCS. GE Medical Systems Trading Development (Shanghai) Co., Ltd. initiated this voluntary recall for its Innova IGS 630 model (Registration No.: CFDA Import 2013 No. 3302661). The core issue identified was a potential malfunction during fluoroscopy on dual-C cardiovascular machines; specifically, releasing the fluoroscopy foot switch while changing the lateral view could lead to system lock-up, loss of X-ray imaging, and necessitate a restart to continue the examination. Fortunately, no patient injuries were reported. While the recall was implemented globally across regions like Europe, Japan, Saudi Arabia, South Korea, Turkey, and the United States, GE confirmed that the affected batches of X-ray machines were not sold or imported into China. Consequently, specific corrective actions for products within China were not required. However, the NMPA requested that provincial Food and Drug Administrations strengthen their supervision and management of similar products to maintain public health standards.

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