Elekta iGUIDE Software 2.2: Incorrect PEC Values Risk Patient Positioning
Elekta recalls iGUIDE Software 2.2 versions due to incorrect PEC values that could affect patient positioning accuracy in radiotherapy. Affected units include iGUIDE 2.2.0 and 2.2.1.
Lower-risk recall
Incorrect PEC values.
Contact the company
What happened, in plain English
Elekta is recalling iGUIDE Software 2.2 versions (2.2.0 and 2.2.1) because incorrect PEC values may lead to inaccurate patient positioning during radiotherapy. This could impact treatment precision and patient safety. Read more at govinfonow.com/recall/73827-elekta-iguide-software-2-2-incorrect-pec-values-risk-patient.
Source Summary by GovInfoNow · govinfonow.com/recall/73827-elekta-iguide-software-2-2-incorrect-pec-values-risk-patient · Updated September 23, 2026 · FDA enforcement record: FDA #Z-3017-2017
Cite this page
“Elekta iGUIDE Software 2.2: Incorrect PEC Values Risk Patient Positioning.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/73827-elekta-iguide-software-2-2-incorrect-pec-values-risk-patient. Based on FDA recall #Z-3017-2017 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3017-2017%22&limit=1).
Why it’s dangerous
Incorrect PEC values in the software could cause the system to misposition patients during radiotherapy. This might lead to inaccurate radiation delivery and potential treatment complications.
Who’s affected
Healthcare professionals using Elekta's iGUIDE software for radiotherapy patient positioning are most at risk. Patients receiving radiotherapy treatments using these software versions may be affected.
How to tell if you have this one
Check for iGUIDE software versions 2.2.0 or 2.2.1. The software is used in radiotherapy environments for patient positioning with a 30 Tracking System.
- Brand
Elekta- Category
Medical device
What to do — step by step
Check Software Version
Identify if your iGUIDE software is version 2.2.0 or 2.2.1 by checking the software settings or documentation.
Where it went and when
Where it was distributed
Distributed in 20 states, and outside the U.S.
FDA distribution: “Worldwide Distribution in the states of AK, CT, GA, KY, LA, MA, MD, MN, NC, NM, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA and countries of Hawaii Australia, Austria, Belgium, Denmark, France, Germany, Hong Kong, India, Indonesia, Ireland,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alaska, Connecticut, Georgia, Kentucky, Louisiana, Maryland, Massachusetts, Minnesota, New Mexico, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington.
Recall timeline
FDA terminated this recall 2.4 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.
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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-3017-2017 (June 19, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3017-2017 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.