China NMPA Product Recall - Oxylog 3000, Oxylog 3000 Plus

Dräger Medical Devices (Shanghai) Co., Ltd., representing manufacturer Drägerwerk AG & Co. KGaA, initiated a voluntary Class I recall for its Oxylog 3000 and Oxylog 3000 Plus emergency and transport ventilators. This action was reported to the National Medical Products Administration (NMPA) on February 21, 2017, following the company's internal discovery of a critical product malfunction. The main issue identified is that affected ventilators may display a "potentiometer not connected/disconnected" error. This error triggers alarms, releases system pressure, and halts ventilation, presenting a serious health risk to patients dependent on the device. No injuries were reported at the time of the recall. In adherence to NMPA's medical device recall regulations, Dräger's required actions involved issuing safety notices to customers, deploying maintenance teams to upgrade the ventilator system software, and distributing an additional instruction manual page to ensure safe operation. Globally, 404 units were affected, with 152 Oxylog 3000 and 252 Oxylog 3000 Plus units sold in China.