China NMPA Product Recall - Whole-body X-ray computed tomography system

GE Medical Systems, LLC, via its subsidiary GE Medical Systems Trade Development (Shanghai) Co., Ltd., initiated a voluntary recall for specific models and batches of its whole-body X-ray computed tomography (CT) systems and other related products. Announced on November 16, 2021, under National Medical Products Administration (NMPA) Index No. JGXX-2021-10623, this action addresses a significant concern. The core issue involves a potential malfunction where the SmartStep option may display incorrect dosage information during interventional surgical procedures. This presents a critical safety risk, necessitating the recall of devices with registration certificate No. 20143065741. Classified as a Level II recall, this designation indicates that exposure to the affected product could cause temporary or medically reversible adverse health consequences, or that the likelihood of serious adverse health consequences is remote. GE Medical Systems, LLC is responsible for implementing this corrective action to safeguard patient well-being and ensure device accuracy. The NMPA provides oversight for this regulatory measure, and comprehensive details on affected product models, specifications, and batch numbers are available in the accompanying Medical Device Recall Event Report Form to guide healthcare providers.