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Lower risk Medical device recall · FDA · Published March 4, 2022

Draegar Infinity CentralStation Software Versions VG2.1.2 and VG2.1.2 SU12: Temporary Loss

Draegar recalls specific versions of Infinity CentralStation software for patient monitoring with Infinity M300 devices. This software issue may cause temporary loss of central monitoring functionality. Affected units have unique identifiers listed in the recall notice.

🇺🇸 FDA recall #Z-1012-2022Medical deviceDraegar ›
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Contact the company

Recalling firmDraegar Medical Systems, Inc.6 Tech Dr · Andover, MA 01810-2434
✎ GovInfoNow plain-language explainer

What happened, in plain English

Draegar is recalling specific versions of their Infinity CentralStation software (VG2.1.2 and VG2.1.2 SU12) that are used with Infinity M300 wireless telemetry devices. The software issue can cause temporary loss of central monitoring functionality, which may impact patient safety during monitoring. This recall does not involve physical hardware but software updates. Read more at govinfonow.com/recall/60986-draegar-infinity-centralstation-software-versions-vg2-1-2-and-vg2.

Source Summary by GovInfoNow · govinfonow.com/recall/60986-draegar-infinity-centralstation-software-versions-vg2-1-2-and-vg2 · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1012-2022

Cite this page

“Draegar Infinity CentralStation Software Versions VG2.1.2 and VG2.1.2 SU12: Temporary Loss.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60986-draegar-infinity-centralstation-software-versions-vg2-1-2-and-vg2. Based on FDA recall #Z-1012-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1012-2022%22&limit=1).

Why it’s dangerous

The software issue causes temporary loss of central monitoring functionality for patient monitoring systems. This means that during certain periods, the system might not properly track patient status, potentially leading to missed alerts or delayed responses. However, the issue is temporary and does not cause permanent damage to the system.

Who’s affected

Healthcare facilities using Draegar Infinity CentralStation software versions VG2.1.2 and VG2.1.2 SU12 with Infinity M300 wireless telemetry devices are most at risk. The issue affects the software, not the hardware, and is temporary.

How to tell if you have this one

Check if your Infinity CentralStation software version is VG2.1.2 or VG2.1.2 SU12. The unique device identifiers (UDIs) listed in the recall notice include specific serial numbers for US distribution. The software is used with Infinity M300 wireless telemetry devices.

  • Brand
    Draegar
  • Product
    Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Software Version

    Verify your Infinity CentralStation software version is VG2.1.2 or VG2.1.2 SU12 by checking the device settings or documentation.

  2. Update Software

    Install the corrected software version from Draegar's official website to resolve the temporary monitoring issue.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 24 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: nationwideMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: nationwideGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, FL, IA, ID, IL, IN, LA, MN, MS, NC, NE, NH, NY, OH, PA, SD, TN, TX, WA, WI, and 58 additional foreign countries.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Florida, Idaho, Illinois, Indiana, Iowa, Louisiana, Minnesota, Mississippi, Nebraska, New Hampshire, New York, North Carolina, Ohio, Pennsylvania, South Dakota, Tennessee, Texas, Washington, Wisconsin.

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: Mar 4, 202212. FDA classified it Class II: Apr 27, 202223. Published in FDA’s Enforcement Report: May 4, 202232022
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

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-1012-2022 (March 4, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1012-2022 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA