China NMPA Product Recall - Aespire and Aestiva/57100 anesthesia systems

The National Medical Products Administration (NMPA) announced a voluntary recall initiated by Datex-Ohmeda, Inc., through its Chinese entity, GE Healthcare Systems Trade Development (Shanghai) Co., Ltd., with a report date of March 5, 2012, and publication on March 14, 2012. This recall affects specific models of Datex-Ohmeda's Aespire and Aestiva/57100 Anesthesia Systems, totaling 987 units imported and sold in China.The primary issues identified for the Aespire model concern its failure to provide an oxygen supply connection method that aligns with national standards, specifically lacking a compliant backup oxygen interface. For the Aestiva/57100 model, similar non-compliance was found regarding the absence of a national-standard backup oxygen supply connection. Additionally, this model utilized color codes that did not meet the required national specifications. These deficiencies pose potential safety risks as they relate to critical oxygen delivery systems in medical devices.Under the NMPA's regulatory oversight, Datex-Ohmeda, Inc. is implementing corrective actions. For the Aespire systems, the company will add a compliant backup oxygen interface. For the Aestiva/57100 systems, the required actions include adding a backup oxygen interface and replacing non-compliant labels with ones adhering to national standards, ensuring proper color coding is addressed. The NMPA has also directed all provincial and municipal food and drug administrations to enhance their supervision and management of these products to ensure public safety and compliance with national regulations.