Brainlab ExacTrac Software Recall: DIBH Functionality May Not Work Correctly
Brainlab recalls ExacTrac Dynamic software models 20910-01E and 20910-01F (versions 1.1.0-1.1.1) due to potential DIBH functionality issues in radiation therapy workflows.
Lower-risk recall
Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a standard-workflow Treatment Template
Contact the company
What happened, in plain English
Brainlab is recalling specific software versions for radiation therapy systems because the Deep Inspiration Breath Hold feature might not function properly during standard treatment templates. This could affect treatment accuracy if the software doesn't respond correctly to breathing patterns. Read more at govinfonow.com/recall/58893-brainlab-exactrac-software-recall-dibh-functionality-may-not-work-correctly.
Source Summary by GovInfoNow · govinfonow.com/recall/58893-brainlab-exactrac-software-recall-dibh-functionality-may-not-work-correctly · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1259-2023
Cite this page
“Brainlab ExacTrac Software Recall: DIBH Functionality May Not Work Correctly.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58893-brainlab-exactrac-software-recall-dibh-functionality-may-not-work-correctly. Based on FDA recall #Z-1259-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1259-2023%22&limit=1).
Why it’s dangerous
The software's Deep Inspiration Breath Hold feature may not work as intended when following standard treatment templates. This could lead to inaccurate radiation delivery if the system doesn't properly track breathing patterns during treatment.
Who’s affected
Patients receiving radiation therapy using Brainlab ExacTrac systems with the recalled software versions are most at risk. Healthcare providers using these systems for treatment planning may also be affected.
How to tell if you have this one
Check if your Brainlab ExacTrac system has software versions 1.1.0 or 1.1.1. The product was sold with GTIN 04056481143978 and models 20910-01E or 20910-01F.
- Brand
Brainlab- Product
Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F- Category
Medical device
What to do — step by step
Check Software Version
Verify your software version by checking the system settings or documentation for versions 1.1.0 or 1.1.1.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 23 states.
FDA distribution: “US Nationwide distribution in the states of AZ, AR, CA, CO, FL, GA. IL, IN, KY, LA, MS, MO, NJ, NY, NC, ND, OK, OR, PA, TN, TX, VA, and WA. There was no government/military distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, Arkansas, California, Colorado, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Mississippi, Missouri, New Jersey, New York, North Carolina, North Dakota, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington.
Recall timeline
FDA published this recall 36 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- 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-1259-2023 (February 14, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1259-2023 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.