# China NMPA Product Recall - Diagnostic image processing software

Source: https://www.globalkeysolutions.net/records/china_product_recall/ge-medical-systems-scs/05f3e2c1-d741-4faa-bc2d-e80f3722c2d7/
Source feed: China

> China NMPA product recall for Diagnostic image processing software by GE Medical Systems SCS published October 08, 2013. Recall level: . The National Medical Products Administration (NMPA) issued a recall, published on October 8, 2013, f

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: GE Medical Systems SCS recalls diagnostic image processing software
- Company Name: GE Medical Systems SCS
- Publication Date: 2013-10-08
- Product Name: Diagnostic image processing software
- Recall Reason: GE recently discovered that the GSI Viewer application running on AW/Volume Share or AW Server displays images in an "up" orientation when a batch is created and the batch group is rotated 180 degrees clockwise (from "bottom" to "top"). The orientation description on the image is correct. The problem is that the patient's right/left side is presented from an "up" perspective, which can lead to misinterpretation and misdiagnosis of the image.
- Discovering Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Manufacturing Company: GE Medical Systems SCS
- Summary: The National Medical Products Administration (NMPA) issued a recall, published on October 8, 2013, for Diagnostic Image Processing Software (model AW Volume Share 4) manufactured by GE Medical Systems SCS. This voluntary recall, reported on September 24, 2013, addresses a critical software defect affecting 234 units in China and globally. The main issue is that the GSI Viewer application, when rotating batch groups 180 degrees clockwise, displays images in an incorrect "up" orientation. Although the on-screen orientation description is accurate, the patient's right/left side is presented from an upward perspective. This error could lead to significant misinterpretation of diagnostic images and potentially result in misdiagnosis. To mitigate this risk, GE Medical Systems SCS has outlined two required actions: customers are being instructed to diligently follow user manual guidelines, combining all available information from 3D reconstructions with original raw data for consistent image interpretation. Additionally, GE Healthcare will provide a free software update package to all affected systems, with service representatives contacting users to ensure the prompt and proper implementation of this corrective measure.

Company: https://www.globalkeysolutions.net/companies/ge-medical-systems-scs/7eda2422-02cb-413a-8d7d-411a779dd49c/