China NMPA Product Recall - Single-photon emission computed tomography (SPECT/CT) system

GE Medical Systems Israel, Functional Imaging, initiated a Class II voluntary recall of its SPECT/CT system, including the Optima NM/CT 640 model. This action, reported by GE Healthcare Systems Trade Development (Shanghai) Co., Ltd. on April 17, 2019, and published by the National Medical Products Administration (NMPA) on May 7, 2019, addresses a critical safety concern. The primary issue identified was improperly tightened detector screws in a very small number of SPECT devices. Loose screws could potentially lead to the detector falling during operation, posing a risk of severe or life-threatening injury to users or patients. The recall was enacted under the NMPA's regulatory framework for medical device safety. Significantly, the affected product batches were not sold or distributed within China. Consequently, GE Healthcare China has not received any domestic complaints, adverse event reports, or injury claims related to this specific problem. Therefore, the required action within China was limited to formally reporting the potential issue to the National Medical Products Administration. Globally, GE Healthcare is committed to correcting all affected systems to mitigate the identified safety risk. The company emphasized the importance of ensuring awareness of all potential risks before these corrections are fully implemented.