China NMPA Product Recall - Mobile C-arm X-ray machine

On June 18, 2019, Medtronic (Shanghai) Management Co., Ltd. initiated a Class II voluntary recall for its mobile C-arm X-ray machine (Registration Certificate No.: 20153302685). This action was reported to the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration. The recall stems from critical issues affecting product functionality and patient care.The primary concerns involve a potential malfunction of the charging board, which can prevent the battery from fully charging. This defect may lead to the O-arm 1000 system failing to generate X-rays, necessitating the physical opening of the gantry and relocation of the system for repair or battery replacement. Such disruptions significantly impede normal operations within surgical environments. Additionally, field use has revealed instances of fuses blowing within the mobile imaging station (MVS), resulting in system failures to power on, charge effectively, or maintain adequate battery levels. These malfunctions pose significant operational challenges, potentially delaying critical medical procedures. Medtronic is providing detailed information on affected models and batches via a Medical Device Recall Event Report Form.