Draegar Medical Systems, Inc. recalls Draeger Medical Systems Infinity Acute Care System (M540) Catalog Numbers: MK31501/MK31701/MK31722
- Recall date
- June 6, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2734-2017
- FDA classification
- Class II
- Brand / firm
- Draegar Medical Systems, Inc.
- Sold / distributed
- 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
Why it was recalled
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Draeger Medical Systems Infinity Acute Care System (M540) Catalog Numbers: MK31501/MK31701/MK31722
Get recall alerts
Free email alert whenever Draegar Medical Systems, Inc. has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Draegar Medical Systems, Inc.