China NMPA Product Recall - Digital mobile X-ray machine, mobile digital-type general-purpose integrated X-ray diagnostic device

Fujifilm (China) Investment Co., Ltd., on behalf of Fujifilm Corporation, has initiated a voluntary Class II recall of its Digital Mobile X-ray Machine (National Medical Device Registration Certificate No. 20222060327). This recall, publicly announced by the National Medical Products Administration (NMPA) on June 14, 2023, addresses critical safety concerns with specific batches of the device. The primary issues identified include a potential for the robotic arm, which connects and secures the X-ray tube, to break under certain operational conditions. Additionally, the devices exhibited X-ray deviation when the light irradiation field was adjusted close to its maximum setting. These malfunctions indicate a failure to comply with the requirements of the IEC60601-2-54 standard, which governs the safety and essential performance of medical electrical equipment. The company is undertaking this recall to mitigate potential risks to patient and operator safety. Affected product models, specifications, and batch numbers are detailed in the accompanying "Medical Device Recall Event Report Form." This proactive measure by Fujifilm demonstrates a commitment to product quality and regulatory compliance, ensuring the safety of medical devices in clinical use.