GE Healthcare Recalls CARESCAPE R860 Ventilators Due to Oxygen Sensor Inaccuracy

Source: China Economic Net

Beijing, September 22 (CECN Reporter He Xiao, Ma Xianzhen) — The National Medical Products Administration website recently issued an announcement regarding the voluntary recall of ventilators by Datex-Ohmeda, Inc. Recently,General ElectricMedical System Trade Development (Shanghai) Co., Ltd. reported that due to potential issues with oxygen sensors in specific models and batches of products, which may cause the displayed FiO2 values to inaccurately reflect the actual delivered oxygen concentration, the manufacturer Datex-Ohmeda, Inc. has initiated a voluntary recall of ventilators (Registration Certificate No.: Guo Xie Zhu Jin 20173541051). The recall is classified as Class II.

The products subject to this recall are ventilators, with the model and specification being CARESCAPE R860. The registration certificate or filing voucher number is Guo Xie Zhu Jin 20173541051. The manufacturer is Datex-Ohmeda, Inc., and the agent is GE Healthcare System Trade Development (Shanghai) Co., Ltd. The reason for the recall is that GE Healthcare recently discovered potential issues with the oxygen sensors in certain batches of CARESCAPE R860 devices, which may result in the displayed FiO2 values not accurately reflecting the actual delivered oxygen concentration. No reports of harm caused by this issue have been received to date.

The countries and regions involved in this recall include the United States, Canada, and others.

A query by a reporter from China Economic Net revealed that GE Healthcare Systems Trade Development (Shanghai) Co., Ltd. is a wholly-owned subsidiary of GE (China) Co., Ltd., which in turn is a subsidiary of General ElectricPacific OceanA wholly-owned subsidiary of a private limited company.

　　GEGE Healthcare is the healthcare business unit of GE Group (NYSE: GE), with annual revenue exceeding $17 billion. With a rich history spanning over 100 years, it employs approximately 56,000 people across more than 160 countries worldwide. Committed to becoming an innovator leading precision medicine, GE Healthcare provides intelligent devices, data analytics, software applications, and services, establishing a comprehensive precision medicine ecosystem that covers disease diagnosis, treatment, and monitoring. GE Healthcare began its operations in China in 1979 and established its first office in Beijing in 1986. Currently, GE Healthcare has set up multiple operating entities in China, including wholly-owned and joint ventures, employing nearly 7,000 staff members, including a research and development team composed of over 1,000 engineers, developing leading medical products and technologies for China and the world. In the 2019 Top 100 Global Medical Device Companies ranking, GE Healthcare ranked fourth, with revenue reaching $19.784 billion.

Datex-Ohmeda, Inc. is a company that manufactures anesthesia machines, ventilators, and monitoring equipment. In 2003, GE Healthcare acquired Datex-Ohmeda from DRE.