GE Healthcare Issues Class I Recall for 421 Units in China Due to Critical Device Defects

▍Source: National Medical Products Administration

Change Recall Level

On March 4, according to the National Medical Products Administration,Report by General Electric Medical Systems Trade Development (Shanghai) Co., Ltd.

Due to loose cable connections within the product, the manufacturer Datex-Ohmeda, Inc. has initiated a voluntary recall of the Anesthesia System (Registration Certificate No.: Guo Xie Zhu Jin 20183540068).

Relevant recall information was released on December 23, 2019.The recall level was Class II, and it is now being changed to Class I.For detailed information such as the product name, registration certificate or filing voucher number, model, specifications, and batch number, please refer to the “Medical Device Recall Event Report Form.”

408 units in China

General Electric Medical Systems Trade Development (Shanghai) Co., Ltd. reported that, due to the potential failure of respiratory module sensors, the manufacturers GE Healthcare Finland Oy and Datex-Ohmeda, Inc. have voluntarily recalled Patient Monitors (Registration Certificate No.: Guo Shi Yao Jian Xie (Jin) Zi 2014 No. 3212922), Anesthesia Systems (Registration Certificate No.: Guo Shi Yao Jian Xie (Jin) Zi 2014 No. 3542837), and Anesthesia System (Registration Certificate No.: Guo Xie Zhu Jin 20183540068).

The relevant recall information was released on November 4, 2019, with the recall classified as Class II; the recall classification is now being changed to Class I.For detailed information including the product name, registration certificate or filing voucher number, model, specifications, and batch numbers, please refer to the "Medical Device Recall Event Report Form."