Elekta iGUIDE System Software Recalls: Incorrect 3D Position Monitoring
Elekta recalls iGUIDE System software versions 2.2.0-2.2.2 due to potential incorrect 3D position monitoring. Affected units have specific GTIN numbers and were sold with these software builds.
Lower-risk recall
Potential for iGUIDE to incorrectly monitor the 3D position.
Contact the company
What happened, in plain English
Elekta is recalling iGUIDE System software versions 2.2.0, 2.2.1, and 2.2.2 because they might monitor 3D position incorrectly. This could affect medical procedures requiring precise positioning. Read more at govinfonow.com/recall/67643-elekta-iguide-system-software-recalls-incorrect-3d-position-monitoring.
Source Summary by GovInfoNow · govinfonow.com/recall/67643-elekta-iguide-system-software-recalls-incorrect-3d-position-monitoring · Updated August 20, 2026 · FDA enforcement record: FDA #Z-2230-2019
Cite this page
“Elekta iGUIDE System Software Recalls: Incorrect 3D Position Monitoring.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/67643-elekta-iguide-system-software-recalls-incorrect-3d-position-monitoring. Based on FDA recall #Z-2230-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2230-2019%22&limit=1).
Why it’s dangerous
The software might incorrectly track the 3D position of medical devices during procedures. This could lead to inaccurate positioning of surgical tools or implants, potentially causing complications during surgery.
Who’s affected
Medical professionals using the iGUIDE System for procedures requiring precise 3D positioning are most likely affected. Patients using this system during medical procedures may be at risk if the software fails.
How to tell if you have this one
Check if your iGUIDE System has software build versions 2.2.0, 2.2.1, or 2.2.2. Affected units have specific GTIN numbers: 04056719001704, 04056719001742, or 04056719002039.
- Brand
Elekta- Product
iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2- Category
Medical device
What to do — step by step
Check Software Version
Look for the software build number on your iGUIDE System to see if it is 2.2.0, 2.2.1, or 2.2.2.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 35 states.
FDA distribution: “Nationwide distribution to AK, AL, CA, CO, CT, FL, GA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI. Worldwide distribution to Algeria, Argentina, Australia, Austria,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Vermont, Virginia, Washington, Wisconsin.
Recall timeline
FDA terminated this recall 4.9 years 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.
Questions people ask
Do I need to do anything if my software is not affected?
No action is needed if your software version is not 2.2.0, 2.2.1, or 2.2.2.
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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-2230-2019 (June 19, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2230-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 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.