Draeger Infinity Acute Care System M540: Audio/Visual Alarms May Not Work
Draeger Medical Systems recalls Infinity Acute Care System (M540) with catalog numbers MK31501/MK31701/MK31722 and specific serial numbers due to potential failure to alert users of critical medical conditions.
Use caution until it’s fixed
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.
Contact the company
What happened, in plain English
Draeger Medical Systems is recalling certain Infinity Acute Care System (M540) models because some units may not properly sound or show alarms when critical medical conditions occur. This could delay life-saving alerts for patients. Read more at govinfonow.com/recall/73937-draeger-infinity-acute-care-system-m540-audio-visual-alarms-may.
Source Summary by GovInfoNow · govinfonow.com/recall/73937-draeger-infinity-acute-care-system-m540-audio-visual-alarms-may · Updated September 23, 2026 · FDA enforcement record: FDA #Z-2734-2017
Cite this page
“Draeger Infinity Acute Care System M540: Audio/Visual Alarms May Not Work.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/73937-draeger-infinity-acute-care-system-m540-audio-visual-alarms-may. Based on FDA recall #Z-2734-2017 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2734-2017%22&limit=1).
Why it’s dangerous
The system may fail to alert users through audio or visual alarms when critical medical conditions occur, which could delay life-saving responses. This happens in units with revision index 06 or higher that contain 4GB RAM modules.
Who’s affected
Healthcare providers using the Infinity Acute Care System (M540) with catalog numbers MK31501/MK31701/MK31722 and specific serial numbers listed in the recall are most at risk. These units are used in medical settings where timely alarms are critical.
How to tell if you have this one
Check for catalog numbers MK31501, MK31701, or MK31722 on the product. Also look for specific serial numbers listed in the recall document, which include both US and OUS numbers starting with 401089026 and other codes.
- Brand
Draeger- Category
Medical device
What to do — step by step
Check Product Details
Verify your Infinity Acute Care System (M540) has catalog numbers MK31501, MK31701, or MK31722 and matches the serial numbers listed in the recall.
Where it went and when
Where it was distributed
Distributed in 5 states, and outside the U.S.
FDA distribution: “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…” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, New Hampshire, South Dakota, Tennessee, Texas.
Recall timeline
FDA terminated this recall 12 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2734-2017 (June 6, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2734-2017 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.