China NMPA Product Recall - Emergency ventilator Oxylog 3000, Oxylog 3000 Plus

Dräger Medical Devices (Shanghai) Co., Ltd., under the purview of the National Medical Products Administration (NMPA), initiated a Class I voluntary recall for its Oxylog 3000 and Oxylog 3000 Plus emergency and transport ventilators. Published on March 1, 2017, the recall addresses a critical safety concern: affected devices may produce a "potentiometer not connected/disconnected" error. This malfunction triggers an audible and visual alarm, leading to pressure release in the respiratory system and a complete stop of ventilation, posing a serious risk to patients. No injuries have been reported related to this issue. The regulatory framework for this recall is aligned with Chinese medical device standards, indicated by the CFDA and imported medical device registration numbers. Dräger's required corrective actions include issuing safety notices to all relevant customers, deploying maintenance personnel to upgrade the ventilator system software, and providing supplementary instruction manual pages to ensure comprehensive user information.