China NMPA Product Recall - Mobile digital X-ray machine

Agfa Medical Systems Equipment (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its DX-D100 Mobile Digital X-ray Machines, as reported by the National Medical Products Administration (NMPA) on June 2, 2015. The recall was prompted by two significant issues affecting product safety and functionality. Firstly, the company discovered that electrostatic discharge could cause the equipment to move unexpectedly at unpredictable times, posing a potential hazard to operators and patients. Secondly, the device's capacitive touchscreen was prone to misinterpreting liquid contact as user input, leading to unintended operations. The recall affects 50 units in China, with 38 units already sold. In response, Agfa Medical Systems implemented a two-pronged corrective action plan. Customers received immediate cautionary notices advising them to utilize the safety switch for unexpected movements and to ensure hands and touchscreens are dry before use, confirming settings before exposure. Furthermore, the company committed to product upgrades: installing a 1MΩ discharger and updating the Digital Motion Controller (DMC) firmware to resolve the electrostatic discharge and movement issues. Software updates will also be deployed to refine touchscreen functionality and prevent accidental activations. These actions aim to enhance the safety and reliability of the affected devices.