Draeger Medical Systems Infinity Acute Care System (M540)
Medical device recall Z-2734-2017. Published in FDA’s Enforcement Report on Jul 26, 2017.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jul 26, 2017. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 5 states named in where it went
- 37 US and 682 OUS how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Draeger Medical Systems Infinity Acute Care System (M540) Catalog Numbers: MK31501/MK31701/MK31722
37 US and 682 OUS, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial numbers: US: 401089026 401089022 401089020 401089029 401089031 401089033 401089025 401089028 401089003 401089014 401089023 401089024 401089037 401089042 401089012 401089021 401089034 401091057 401091014 401091042 401091076 401091063…
Every code shown here, 1,995 characters
Serial numbers: US: 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: 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 402073024 402073050 402073065 402073049 404235077 404235050 404235053 404235060 402073056 402073053 402073047 404234020 402073043 401089044 401089035 401089049 401089039 401089006 401089032 373821055 376586021 401091003 404234098 404234064 404234074 404234067 404234072 404234075 404234085 404234078 404234087 404234027 404234002 404234003 404234090 404234004 404234023 404234028 404234043 404234096 404234006 404234009 404235015 404234035 404234080 404235016 404235024 404235006 404235029 404235018 404235040 404234082 401089019 401089009 404235038 404235057 402073001 404235061 404235088 404235095 404235066 404235054 404235009 404235055 404235037 404235025 404235004 404235007 404235011 404235005 404234084 404234100 404234057 404234034 404234091 404234052 404235042 404235001 404235028 404235031 404235014 404235021 404234001 404235020 404235039 404235056 404235030 404235036 404235032 404235048 402073008 401089040 402073068 402073012 402073057 404235099 404235070 404235097 404235008 404235080 404235083 404235078 404235065 404235094 404235098…
FDA’s list runs to 5,216 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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
The states and territories these words name
- Arizona
- New Hampshire
- South Dakota
- Tennessee
- Texas
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jun 6, 2017.
- FDA classified it on Jul 14, 2017.
- FDA’s Enforcement Report published it on Jul 26, 2017.
- FDA terminated it on Jun 19, 2018.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Draegar Medical Systems, Inc., of Andover, MA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 5,216 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.