Draeger Medical Systems Infinity Acute Care System (M540) Catalog Numbers: MK31501/MK31701/MK31722

Cockpits with revision index 06 or higher that contain 4GB RAM modules may not annunciate audio or visual alarms on the Cockpit and Central Station.

Draeger issued on June 6, 2017 Urgent Medical Recall letter with Addendum US serial numbers via Certified Mail addressed to Risk Manager and Director Clinical Engineering The letter instructs the consignees, if the serial number of the cockpit is on the serial number list, to remove the Cockpit from use until it can be determined whether the 4GB RAM Module is among those affected. The IACS can be used without the Cockpit and the M540 will function as the primary monitoring device once the Cockpit is disconnected. A DrgerService Representative will schedule a time to inspect the Cockpit and, if necessary, replace the 4GB RAM Module. The inspection and 4GB RAM replacement (if necessary) will be performed free of charge. For questions regarding the Operation and/or servicing the Drger Infinity Acute Care System Cockpit contact DrgerService Technical Support at 800-437- 2437 (press 4 at the prompt and then press 4 again). For OUS the responsible local Draeger Sales and Service will mail the letter with Addendum serial number list.