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

Source: https://www.globalkeysolutions.net/records/china_product_recall/ge-healthcare-systems-trade-development-shanghai-co-ltd/e7648cfa-c921-4f28-878d-94a28b5c0336/
Source feed: China

> China NMPA product recall for Medical angiography X-ray machine by GE Healthcare Systems Trade Development (Shanghai) Co., Ltd. published April 15, 2019. Recall level: Level 2 Recall. On April 15, 2019, GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. initiated a volunt

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd. is voluntarily recalling medical angiography X-ray machines.
- Company Name: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Publication Date: 2019-04-15
- Product Name: Medical angiography X-ray machine
- Recall Level: Level 2 Recall
- Recall Reason: If, during fluoroscopic examination using the product on a two-way fluoroscopic device, the user changes the field of view (FOV) from 30cm to 20cm or vice versa while simultaneously releasing the fluoroscopic foot switch, the X-ray imaging function may be lost. This may cause the system to lock, requiring a system restart to restore operation.
- Discovering Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Manufacturing Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Summary: On April 15, 2019, GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. initiated a voluntary Class II recall of specific medical angiography X-ray machines. This action was reported under National Medical Products Administration (NMPA) Index No. JGXX-2019-10244 and Shanghai Food and Drug Administration Medical Device Registration No. 2019-069. The recall addresses an operational issue identified during fluoroscopy examinations: if a user changes the field of view (FOV) between 30cm and 20cm while simultaneously releasing the fluoroscopy foot switch, the device may lose its X-ray imaging function. This malfunction can result in a system lockout, necessitating a system restart to restore full operation, which could disrupt medical procedures. In response to this potential performance issue, GE Healthcare Systems is voluntarily recalling the affected angiography X-ray machines (Registration Certificate No.: 20173306458). Detailed information regarding the models and batches subject to this recall is available in the associated Medical Device Recall Event Report Form, underscoring the company's commitment to product safety and regulatory compliance.

Company: https://www.globalkeysolutions.net/companies/ge-healthcare-systems-trade-development-shanghai-co-ltd/4d6c1bd7-e2c1-400d-b03c-385df7470df5/