# China NMPA Product Recall - Image archiving and transmission system (Model: Centricity PACS-IW; Version: 3.7.3)

Source: https://www.globalkeysolutions.net/records/china_product_recall/ge-healthcare-china-co-ltd/2b639040-1503-42bf-b617-6de69ec25b9f/
Source feed: China

> China NMPA product recall for Image archiving and transmission system (Model: Centricity PACS-IW; Version: 3.7.3) by GE Healthcare (China) Co., Ltd. published October 14, 2015. Recall level: Level III. GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. initiated a voluntary Class III recal

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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 (China) Co., Ltd.
- Publication Date: 2015-10-14
- Product Name: Image archiving and transmission system (Model: Centricity PACS-IW; Version: 3.7.3)
- Recall Level: Level III
- Recall Reason: When the system parameter "MapRoute" is set to a value greater than 1, it may result in not all images being processed during the examination, thus missing one or more images. There are currently no reports of patient harm caused by this.
- Discovering Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Manufacturing Company: GE Healthcare (China) Co., Ltd.
- Summary: GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. initiated a voluntary Class III recall for its Centricity PACS-IW Image Archiving and Transmission System (version 3.7.3) on October 14, 2015, following a report dated September 10, 2015. This action, overseen by the National Medical Products Administration (NMPA) under CFDA approval, addresses a critical software issue. The main problem arises when the "MapRoute" system parameter is set to a value greater than one, potentially causing certain images to be unprocessed during examinations, leading to missing data. Although no patient injuries have been reported, this defect poses a risk of incomplete medical image records. To mitigate this, GE Healthcare is implementing two key corrective actions. Firstly, an email notification will be sent to all affected customers, providing guidance on safe usage of the system. Secondly, a comprehensive software upgrade will be developed and deployed to permanently rectify the "MapRoute" parameter issue, ensuring all images are processed correctly and preventing future data loss. This recall impacts products sold in various regions, including China, USA, EEA, and Canada.

Company: https://www.globalkeysolutions.net/companies/ge-healthcare-china-co-ltd/54e52bc9-beef-4ac4-a7d7-a5f2c9dbe214/