China NMPA Product Recall - Anesthesia system

On April 21, 2016, the National Medical Products Administration (NMPA) issued a recall notice concerning anesthesia systems manufactured by Datex-Ohmeda, Inc. This voluntary recall, reported in China by GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. (Registration Certificate No.: 20143545300), addresses a significant product issue. The primary concern involves a potential kinking of the vacuum suction tube within the Aisys CS2 anesthesia system. This defect could reduce suction force below the 20 liters per minute required by ISO 10079-3, potentially leading to insufficient airway clearance and incomplete patient ventilation during medical procedures. While no patient injuries have been reported, the issue poses a safety risk. This recall falls under the NMPA's medical device regulatory framework. Although the affected products were not sold in China, the NMPA requested that regional food and drug administrations enhance their oversight of this type of medical device. Datex-Ohmeda, Inc. is implementing corrective actions to address the internal tubing issue. Stakeholders with questions regarding this recall are directed to contact GE Healthcare Systems Trading Development (Shanghai) Co., Ltd.