China NMPA Product Recall - Respiratory therapy system/ventilator

On April 8, 2014, the National Medical Products Administration (NMPA) published a recall notice regarding respiratory therapy systems and other medical products from Draeger Medical GmbH, Germany. This recall, initially reported by the Shanghai Food and Drug Administration on March 28, 2014, addressed critical safety concerns across multiple devices. The primary issues identified included a defective optional power supply in various respiratory therapy systems and ventilators, registered under CFDA Import Medical Device Registration numbers such as 20133541198, 20123541657, and 20143540423. Additionally, emergency and transport ventilators, along with other specific ventilator models (e.g., CFDA Registration No. 20123541658 and 20123542196), were recalled due to malfunctions in the integrated circuit board within their control panels. Affected products encompassed models like the Infinity Acute Care System Workstation (Critical Care and Neonatal Care) and Evita V300 ventilators. Under the regulatory oversight of the NMPA (formerly CFDA), Draeger Medical Equipment (Shanghai) Co., Ltd. facilitated the recall. The manufacturer, Draeger Medical Systems GmbH, was formally requested to enhance its supervision and management of these recalled products. This global recall involved nine units imported or produced, with specific serial numbers identified for units distributed in China, although two Evita V300 units were designated solely for registration testing purposes.