China NMPA Product Recall - X-ray diagnostic equipment (trade name: Navigator); Kodak DirectView DR3000 digital radiography system (model: DR 3000 / Kodak DirectView DR 3500)

Carestream (Shanghai) Medical Devices Co., Ltd. initiated a voluntary Class II recall for specific models of its X-ray diagnostic equipment, including the Navigator and Kodak DirectView DR3000/DR3500 Digital Radiography Imaging Systems. This action, reported via a Shanghai Food and Drug Administration Medical Device Notice on January 19, 2020, addresses a significant safety concern. The issue stems from potentially incorrect factory settings of the "height inverter," a critical component that controls the U-arm's vertical movement. If a technician repeatedly presses the "lower" button on the U-arm, this defect could lead to unexpected U-arm motion. Such uncontrolled movement poses a risk of accidental injury to both users and patients during operation. The recall falls under the regulatory oversight of the National Medical Products Administration (NMPA) and its local affiliate, the Shanghai Food and Drug Administration. Carestream's required action is to conduct this voluntary recall, with specific details on affected product models and batches provided in an accompanying Medical Device Recall Event Report Form. This measure aims to mitigate the identified safety hazard and ensure patient and user safety.