Draegar Medical Systems, Inc. recalls Draeger Medical Systems Infinity Acute Care System (M540) Catalog Numbers: MK31501/MK31701/MK31722

Recalled July 26, 2017 · FDA recall Z-2734-2017 · Draegar Medical Systems

Hazard

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. · FDA Class II

Units

37 US and 682 OUS

Sold at

AZ, NH, SD, TN, TX Foreign: Australia Austria Belgium Canada China Costa Rica France Germany Great Britian Hong Kong India Ireland Italy Japan Malaysia Namibia Netherlands Poland Portugal Russian Fed. South Africa South Korea Spain Sweden Switzerland Thailand Turkey United Kingdom

Description

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.

Product

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

Manufacturer(s)

Draegar Medical Systems, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →