# China NMPA Product Recall - Image archiving and transmission system

Source: https://www.globalkeysolutions.net/records/china_product_recall/ge-healthcare-systems-trade-development-shanghai-co-ltd/22675bbd-8cf2-4842-8b9a-6315bd13e320/
Source feed: China

> China NMPA product recall for Image archiving and transmission system by GE Healthcare Systems Trade Development (Shanghai) Co., Ltd. published August 21, 2019. Recall level: Level 2 Recall. GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. initiated a voluntary Level II recall

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd. is voluntarily recalling its image archiving and transmission systems.
- Company Name: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Publication Date: 2019-08-21
- Product Name: Image archiving and transmission system
- Recall Level: Level 2 Recall
- Recall Reason: Some batches of products may be missing one or more image series during inspection, and the viewer will not display a warning. This causes the system to keep the image files in a temporary location, affecting the integrity of the images acquired during inspection.
- 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 Level II recall for specific batches of its image archiving and transmission system, as announced by the National Medical Products Administration (NMPA) on August 21, 2019. The Shanghai Food and Drug Administration also holds the registration certificate for these medical devices. The primary issue identified is that certain product batches may fail to display one or more image series during medical inspections, without any corresponding warning to the user. This critical defect leads to image files being stored in temporary locations rather than being properly archived, thereby compromising the integrity and completeness of images acquired during patient examinations. In response to this significant flaw affecting data reliability, GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. is undertaking this recall to address the potential for incomplete or lost patient imaging data. Further details regarding the specific models, specifications, and affected batches are available in the accompanying "Medical Device Recall Event Report Form." This action underscores the company's responsibility to ensure the reliability and safety of its medical imaging systems. The recall aims to prevent potential diagnostic inaccuracies that could arise from missing imaging data, highlighting the importance of robust data management in healthcare technology.

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