Company:Draegar Medical Systems, Inc.
Date of Enforcement Report 7/26/2017
Class lI:

PRODUCT

Draeger Medical Systems Infinity Acute Care System (M540) Catalog Numbers: MK31501/MK31701/MK31722.
Recall Number Z-2734-2017

REASON
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..

RECALLING FIRM/MANUFACTURER
Draegar Medical Systems, Inc., Andover, MA on 6/6/2017. Voluntary: Firm Initiated recall is ongling.

VOLUME OF PRODUCT IN COMMERCE
37 US and 682 OUS

DISTRIBUTION
Nationwide and Internationally

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