# 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/355c8a2d-dd2a-4725-9b51-377e1b06bf65/
Source feed: China

> China NMPA product recall for Medical angiography X-ray machine by GE Healthcare Systems Trade Development (Shanghai) Co., Ltd. published May 19, 2021. Recall level: Level 2 Recall. GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. initiated a voluntary Class II recall

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. is voluntarily recalling medical angiography X-ray machines.
- Company Name: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Publication Date: 2021-05-19
- Product Name: Medical angiography X-ray machine
- Recall Level: Level 2 Recall
- Recall Reason: GE Healthcare recently discovered a vertical line appearing in some IGS systems manufactured between February 2020 and March 2021. This vertical line splits the real-time display image into two images of different sizes, and the images move horizontally within the display screen.
- Discovering Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Manufacturing Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Summary: GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. initiated a voluntary Class II recall for its medical angiography X-ray machines, as announced by the National Medical Products Administration (NMPA) via a notice from the Shanghai Municipal Drug Administration on May 19, 2021. The recall addresses a significant product defect discovered by GE Healthcare affecting certain IGS systems manufactured between February 2020 and March 2021. These devices exhibited a critical malfunction where the real-time display image was split by a vertical line, resulting in two distinct images of varying sizes. Furthermore, the images showed erratic horizontal movement within the display screen, potentially compromising diagnostic accuracy and patient safety during medical procedures. This action falls under the regulatory oversight of the NMPA, which ensures the safety and efficacy of medical devices in China. The Class II recall designation indicates that the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. GE Healthcare's proactive measure highlights the company's commitment to product quality and patient safety, aligning with regulatory expectations for addressing identified device non-conformities. Detailed information regarding specific affected models and batches is available in the associated "Medical Device Recall Event Report Form."

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