Reported Jul 26, 2017 · Terminated

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

Draegar Medical Systems, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Draegar Medical Systems, Inc. · 6 Tech Dr · Andover, MA · 01810-2434

Is this the product you have?

  • Draeger Medical Systems Infinity Acute
  • Care System (M540) Catalog NumbersMK31501/MK31701/MK31722
Lot codes and dates
  • Serial numbersUS:
    • 401089026
    • 401089022
    • 401089020
    • 401089029
    • 401089031
    • 401089033
    • 401089025
    • 401089028
    • 401089003
    • 401089014
    • 401089023
    • 401089024
    • 401089037
    • 401089042
    • 401089012
    • 401089021
    • 401089034
    • 401091057
    • 401091014
    • 401091042
    • 401091076
    • 401091063
    • 404234070
    • 404234037
    • 404234011
    • 404234022
    • 404234063
    • 404234095
    • 404234088
    • 404234093
    • 404234010
    • 404234097
  • OUS

    390 of 390 codes

    • 401089048
    • 401089013
    • 401091016
    • 401091078
    • 401091051
    • 401091060
    • 402073009
    • 402073042
    • 402073027
    • 402073062
    • 402073004
    • 404234014
    • 404234039
    • 404234029
    • 404234040
    • 404234069
    • 404234024
    • 404234044
    • 404234032
    • 404234065
    • 404234056
    • 404234048
    • 404234036
    • 404234038
    • 404234025
    • 404234019
    • 404234013
    • 404234015
    • 374271065
    • 379843052
    • 404234018
    • 404234046
    • 401091098
    • 404234066
    • 404234062
    • 404234068
    • 404234071
    • 404234060
    • 404234079
    • 402073021
    • 402073067
    • 402073030
    • 376587013
    • 401089007
    • 401091035
    • 401091085
    • 401091088
    • 402073089
    • 402073063
    • 404234012
    • 401091011
    • 401091048
    • 401091055
    • 401091039
    • 401091047
    • 401091044
    • 401091038
    • 401091068
    • 401091071
    • 402073022
    350603040_1

    96 of 96 codes

    • 354380023
    • 401780039
    • 401780038
    • 401780003
    • 401780024
    • 401780004
    • 401780001
    • 401780005
    • 401780046
    • 401780030
    • 401780012
    • 401780037
    • 401780034
    • 401780032
    • 402074020
    • 402074017
    • 402074012
    • 402074015
    • 401780023
    • 402074021
    • 402074014
    • 402074011
    • 402074016
    • 402074008
    • 350602060
    • 337018060
    • 402074018
    • 402074003
    • 401780051
    • 354380084
    • 402074019
    • 354380097
    • 337018078
    • 350603049
    • 401780002
    • 401780025
    • 401780020
    • 401780026
    • 401780018
    • 401780022
    • 401780029
    • 401780027
    • 401780017
    • 350602014
    • 350602037
    • 374270012
    • 376595073
    • 401780053
    • 401780021
    • 401780042
    • 401780048
    • 401780054
    • 401780035
    • 401780033
    • 401780047
    • 354380073
    • 350603040
    • 354380076
    • 354380055
    • 354380059
Amount recalled
37 US and 682 OUS

Where it was sold

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.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 19, 2018 · Data as of Sep 19, 4:47 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.