Elekta iGUIDE System Software Recalls: Incorrect 3D Position Monitoring

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Contact the company & request your remedy

Recalling firmElekta, Inc.400 Perimeter Center Ter NE Ste 50, N/A · Atlanta, GA 30346-1227

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✎ GovInfoNow plain-language explainer

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.

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
Category
Medical device

Based on the official FDA remedy

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.

✎ GovInfoNow

Questions people ask

What software versions are affected?

Software builds 2.2.0, 2.2.1, and 2.2.2 are affected.

How can I tell if my iGUIDE System is affected?

Check the product code/GTIN numbers: 04056719001704, 04056719001742, or 04056719002039.

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.

Take action

Contact Elekta

We’ve drafted a message you can send Elekta to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-2230-2019 — Elekta Elekta

Hello,

I own a Elekta that is covered by recall Z-2230-2019 from Elekta.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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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.

Elekta, Inc. recalls iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2

Lower-risk recall