China NMPA Product Recall - Single-photon emission computed tomography (SPT) device

The National Medical Products Administration (NMPA) announced a recall (Index No. JGXX-2013-10114) for Single-Photon Emission Tomography (SPECT) devices manufactured by GE Medical Systems Israel, Functional Imaging. This recall, reported by GE Healthcare Systems Trade Development (Shanghai) Co., Ltd., impacts models DiscoveryNM/CT 670, Discovery NM630, and Brivo NM615. The core issue is a potential safety concern where the SPECT detector may contact a patient's elbow during scanning, specifically during lung imaging with the patient's arm raised and without the provided safety armband. This presents a risk of patient injury. Operating under the NMPA's regulatory framework, GE Medical Systems is voluntarily recalling the affected devices. Provincial food and drug administrations are instructed to enhance supervision of these products. Corrective actions include reminding customers to ensure patient limbs stay within the examination table, using the safety armband when arms are raised, and maintaining continuous patient and system monitoring during scans to ensure adequate clearance. Additionally, GE Healthcare will provide free software updates for all affected systems to resolve this safety concern.