Elekta ERGO++: Incorrect DICOM mapping risks wrong treatment angles
Elekta recalls ERGO++ software version 1.7.3+ for stereotactic treatments due to incorrect DICOM mapping of collimator/couch angles, potentially causing inaccurate radiation therapy planning.
Lower-risk recall
Incorrect DICOM mapping of the exported collimator or couch angles from ERGO, which would lead to incorrect rotation of the collimator or couch when using a MLC device for planning.
Contact the company
What happened, in plain English
Elekta is recalling ERGO++ software versions 1.7.3 and higher used in stereotactic radiation treatments. The software may incorrectly map collimator or couch angles, leading to inaccurate treatment planning that could affect patient safety. Read more at govinfonow.com/recall/73084-elekta-ergo-incorrect-dicom-mapping-risks-wrong-treatment-angles.
Source Summary by GovInfoNow · govinfonow.com/recall/73084-elekta-ergo-incorrect-dicom-mapping-risks-wrong-treatment-angles · Updated September 18, 2026 · FDA enforcement record: FDA #Z-0234-2018
Cite this page
“Elekta ERGO++: Incorrect DICOM mapping risks wrong treatment angles.” GovInfoNow, updated September 18, 2026. https://govinfonow.com/recall/73084-elekta-ergo-incorrect-dicom-mapping-risks-wrong-treatment-angles. Based on FDA recall #Z-0234-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0234-2018%22&limit=1).
Why it’s dangerous
The software incorrectly maps exported collimator or couch angles during stereotactic treatments. This can cause the radiation treatment to be misaligned, potentially affecting the accuracy of the radiation dose delivery to the target area.
Who’s affected
Users of Elekta ERGO++ software for stereotactic radiation treatments, particularly those using version 1.7.3 or higher. Patients receiving radiation therapy with this software are at risk of inaccurate treatment planning.
How to tell if you have this one
Check if you have Elekta ERGO++ software version 1.7.3 or higher used for stereotactic radiation treatments. The software is part of Elekta's product line for radiation therapy planning.
- Brand
Elek:ta- Category
Medical device
What to do — step by step
Check Software Version
Verify your Elekta ERGO++ software version; if it is 1.7.3 or higher, it is affected.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 15 states.
FDA distribution: “Worldwide Distribution - US Nationwide in the states of: VA, CA, TX, MO, NY, WA, NM, MA, FL, CT, OK, SC, MS, NY, GA, NC and the countries of: AUSTRALIA, BANGLADESH, BRAZIL, BULGARIA, CANADA, COLOMBIA, CZECH REPUBLIC, ECUADOR, FRANCE,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Connecticut, Florida, Georgia, Massachusetts, Mississippi, Missouri, New Mexico, New York, North Carolina, Oklahoma, South Carolina, Texas, Virginia, Washington.
Recall timeline
FDA terminated this recall 2.2 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-0234-2018 (September 1, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0234-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 18, 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.