Infinity M500 Docking Station

Draeger Medical Systems, Inc. has become aware during testing in conjunction with global market surveillance activities that the Infinity M500 Docking Station is not in full compliance to type CF requirements of IEC 60601-1 and IEC 60601-2-34 standards.

The only ports that could be affected are: Hemo port (gray color), SpO2 port (blue color) and Temp port (white color) on M540. The specific accessories which can be connected to these ports and may be affected are the Dual Hemo MCable, SpO2 MCables, and temperature probes, respectively. 

Recall Start Date: April 15, 2024