China NMPA Product Recall - Diagnostic image processing software

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.