China NMPA Product Recall - Medical angiography X-ray machine

The National Medical Products Administration (NMPA) issued a recall notice on December 19, 2013, regarding medical angiography X-ray machines manufactured by GE Medical Systems SCS. GE Medical Systems Trading Development (Shanghai) Co., Ltd. initiated this voluntary recall for its Innova IGS 630 model (Registration No.: CFDA Import 2013 No. 3302661). The core issue identified was a potential malfunction during fluoroscopy on dual-C cardiovascular machines; specifically, releasing the fluoroscopy foot switch while changing the lateral view could lead to system lock-up, loss of X-ray imaging, and necessitate a restart to continue the examination. Fortunately, no patient injuries were reported. While the recall was implemented globally across regions like Europe, Japan, Saudi Arabia, South Korea, Turkey, and the United States, GE confirmed that the affected batches of X-ray machines were not sold or imported into China. Consequently, specific corrective actions for products within China were not required. However, the NMPA requested that provincial Food and Drug Administrations strengthen their supervision and management of similar products to maintain public health standards.