China NMPA Product Recall - Image processing software NX 3.0

Agfa Medical Systems (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its NX3.0 Image Processing Software, reported to the National Medical Products Administration (NMPA) on January 23, 2017, and published on February 21, 2017. The recall stemmed from a critical software defect related to a memory issue. This defect could lead to unexpected errors and compromised data integrity, potentially causing one patient's image to be archived in another's record, as seen in an overseas incident where warning instructions were not followed. The affected products include 7 demonstration units manufactured in China, impacting various regions in Asia, New Zealand, India, Thailand, and Hong Kong. In response to this issue, Agfa Medical Systems mandated two key corrective actions. First, customers received a cautionary notice advising them to perform daily restarts of their NX workstations and to meticulously follow all on-screen warning messages, restarting the workstation if messages appear. Second, the company committed to releasing a new software version, NX 3.0.9000, designed to provide a permanent solution to the identified memory and data integrity problems.