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GE Healthcare Finland Oy and Datex-Ohmeda, Inc Recall

2020-03-07

GE Healthcare Finland Oy and Datex-Ohmeda, Inc voluntarily recalled its Patient Monitor and two anesthesia systems due to the breathing module sensor may be invalid. Relevant recall information has been released with Recall Level 2 on November 4, 2019, but now the recall level is changed to Level 1. Recall Level 1 is the most serious case. Since China NMPA enhances the post-market surveillance, Bradynuoen can help manufacturers handle AE and recalls in compliance to China regulations.

Link: http://www.nmpa.gov.cn/WS04/CL2134/375268.html