FDA-Device2017-07-26Class II
Draeger Medical Systems Infinity Acute Care System (M540) Catalog Numbers: MK31501/MK31701/MK31722
Draegar Medical Systems, Inc.
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.
Sold states
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
Affected count
37 US and 682 OUS
Manufactured in
6 Tech Dr, N/A, Andover, MA, United States
Products
Draeger Medical Systems Infinity Acute Care System (M540) Catalog Numbers: MK31501/MK31701/MK31722
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2734-2017Don't want to check this manually?
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