China NMPA Product Recall - Digital X-ray machine

Beijing GE Healthcare Co., Ltd. initiated a voluntary Level 1 recall for specific models of its digital X-ray machines, namely Definium Tempo and Definium Tempo Pro. This action, reported on November 13, 2023, by the National Medical Products Administration (NMPA) of China, addresses a critical product defect. The primary issue involves the potential loosening of bolts within the X-ray tube suspension device (OTS) assembly, which can lead to operational noise. The affected products include digital X-ray machines identified by registration numbers 京械注准20212060358 and 京械注准20212060418. A Level 1 classification indicates a high potential for serious health consequences or death due to the defect. As a required action, Beijing GE Healthcare Co., Ltd. has taken steps to remove these devices from circulation to mitigate any risks to patients and healthcare providers. Further specifics regarding the exact models, specifications, and affected batches are detailed in the "Medical Device Recall Event Report Form," which serves as the official document outlining the scope and handling of this recall under the NMPA's regulatory oversight. This proactive measure ensures compliance with medical device safety standards and protects public health.