# 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/7240f87c-3940-446c-bf43-848746218ac8/
Source feed: China

> China NMPA product recall for Image archiving and transmission system by GE Healthcare Systems Trade Development (Shanghai) Co., Ltd. published December 05, 2018. Recall level: Level 3 Recall. On December 5, 2018, the National Medical Products Administration (NMPA) publicized a voluntary Clas

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. voluntarily recalls image archiving and transmission systems.
- Company Name: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Publication Date: 2018-12-05
- Product Name: Image archiving and transmission system
- Recall Level: Level 3 Recall
- Recall Reason: When dealing with product images that are flipped, the image orientation markers may sometimes be displayed incorrectly.
- Discovering Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Manufacturing Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Summary: On December 5, 2018, the National Medical Products Administration (NMPA) publicized a voluntary Class III recall initiated by GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. The recall pertains to their image archiving and transmission systems, identified by registration certificates including 国食药监械（进）字2014第2702186号 and 国械注进20182701756. The primary concern leading to this action is a critical software defect: when images are flipped within the system, their orientation markers may occasionally display incorrectly. This malfunction can lead to misinterpretation of medical images, potentially impacting diagnostic accuracy and patient care. Under the NMPA's regulatory framework for medical devices, GE Healthcare is undertaking this voluntary recall to address the non-conformance. The company is responsible for providing comprehensive details, including the specific models, specifications, and batch numbers of all affected devices, within a "Medical Device Recall Event Report Form." This proactive measure underscores GE Healthcare's commitment to product safety and regulatory compliance, aiming to rectify the identified issue and ensure the continued reliability and accuracy of its medical imaging systems for healthcare providers.

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