China NMPA Product Recall - Water collector (Model: D-Fend)

GE Healthcare Trading Development (Shanghai) Co., Ltd., under the oversight of the National Medical Products Administration (NMPA), initiated a voluntary Class III recall on April 15, 2015, concerning its D-Fend collectors (model: 876446-HEL). The recall was prompted by a potential risk of clogging in the D-Fend collector, a component used in various GE Healthcare patient monitors, anesthesia machines, and ventilators, including specific models like the B850 and B650 Patient Monitors, Aisys and Avance CS2 Anesthesia Systems, and Engstrom Carestation Ventilators. Clogging can occur immediately after installation and compromise gas monitoring in patient breathing circuits. This malfunction triggers audible alarms and on-screen messages such as "Low sampling gas flow" or "Sampling line blocked," indicating a critical issue in patient care. The recall affects 158 units in China and extends to the United States, European Economic Area, Canada, and other regions. As part of the corrective actions, GE Healthcare is instructing customers to discard affected D-Fend collectors and will provide replacements upon receipt of a completed reply form. This proactive measure ensures patient safety by addressing the identified functional defect.