China NMPA Product Recall - Oxylog 3000, Oxylog 3000 Plus

Dräger Medical Devices (Shanghai) Co., Ltd. initiated a Class I voluntary recall of its Oxylog 3000 and Oxylog 3000 Plus emergency and transport ventilators. Published by the National Medical Products Administration (NMPA) on February 21, 2017, this action addresses a critical safety issue. The company identified that affected ventilators might display a "potentiometer not connected/disconnected" error. This malfunction triggers audible and visual alarms, results in pressure release within the respiratory system, and causes the device to stop ventilating the patient. While no injuries were reported, the potential for serious adverse health consequences led to the Class I recall designation. To rectify this, Dräger issued safety notices to customers, dispatched maintenance teams to perform a system software upgrade on the ventilators, and provided supplementary pages for the instruction manuals. Globally, 404 units were affected, with 152 Oxylog 3000 and 252 Oxylog 3000 Plus units distributed in China requiring these immediate corrective measures.