Use caution Medical device recall · FDA · Published February 14, 2018

Brainlab ExacTrac Software Versions 6.0-6.5 May Cause Misinterpretation of Beam

Brainlab recalls ExacTrac software versions 6.0-6.5 for possible misinterpretation of beam authorization when used with certain radiation therapy systems, requiring users to follow specific safety steps.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1006-2018Medical device Brainlab ›

Use caution until it’s fixed

The usage of workflows that deviate from the recommended specifications in the User manual for ExacTrac Patient Positioning System (versions 6.0, 6.1, 6.2, 6.5) with Auxiliary Device Interface (ADI) and Varian Clinac or Varian TrueBeam, which may result in misinterpretation of beam authorization via ADI.

Take action

Contact the company

Recalling firmBrainlab AGOlof-Palme-Strasse 9 · Munich, Germany

✎ GovInfoNow plain-language explainer

Brainlab is recalling ExacTrac software versions 6.0 through 6.5 that may misinterpret beam authorization when used with Varian Clinac or TrueBeam radiation therapy systems. This could lead to incorrect radiation treatment delivery if users deviate from recommended software specifications. Read more at govinfonow.com/recall/71961-brainlab-exactrac-software-versions-6-0-6-5-may-cause.

Source Summary by GovInfoNow · govinfonow.com/recall/71961-brainlab-exactrac-software-versions-6-0-6-5-may-cause · Updated August 28, 2026 · FDA enforcement record: FDA #Z-1006-2018

Cite this page

“Brainlab ExacTrac Software Versions 6.0-6.5 May Cause Misinterpretation of Beam.” GovInfoNow, updated August 28, 2026. https://govinfonow.com/recall/71961-brainlab-exactrac-software-versions-6-0-6-5-may-cause. Based on FDA recall #Z-1006-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1006-2018%22&limit=1).

The FDA announced on Feb. 14, 2018, that Brainlab AG is recalling ExacTrac versions 6.5 through 6.5 positioning systems. The hazard involves potential misinterpretation of beam authorization via the Auxiliary Device Interface when workflows deviate from user manual specifications.

How to tell if you have it

Brand: Brainlab
Product: ExacTrac versions 6.0, 6.1, 6.2, and 6.5
GTIN for ExacTrac 6.2: 04056481000264
GTIN for ExacTrac 6.5: 04056481138400
Units affected: 587 systems

The hazard

According to the FDA, using workflows that deviate from recommended specifications for ExacTrac Patient Positioning System versions 6.0, 6.1, 6.2, and 6.5 with Auxiliary Device Interface (ADI) and Varian Clinac or Varian TrueBeam may result in misinterpretation of beam authorization via ADI.

Context

GovInfoNow's records show Brainlab AG has 15 other recalls on record since July 28, 2017. Recent similar recalls include the Feb. 10, 2025 recall of Brainlab Origin Data Management Software for merging patient records and the March 2, 2023 recall of the Brainlab Cirq Arm System 2.0 for mechanical instability risks. Other recent recalls of similar products include the Nov. 28, 2025 RayStation 10B Software recall for radiation dose errors and the Nov. 28, 2025 RayStation/RayPlan 10B Software recall for radiation dose calculation risks.

How to tell if you have this one

Check if your ExacTrac software version is 6.0, 6.1, 6.2, or 6.5. The software is used with Varian Clinac or TrueBeam systems for radiation therapy procedures. The GTIN numbers listed in the recall include specific codes for these versions.

Brand
Brainlab
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Identify your ExacTrac software version by checking the product documentation or the software interface for versions 6.0, 6.1, 6.2, or 6.5.
Follow Manufacturer Guidelines
Ensure you are using the software according to the recommended specifications in the User Manual to avoid misinterpretation of beam authorization.

How this recall unfolded

Recall timeline

FDA terminated this recall 3.3 years after the firm started it.

Feb 14, 2018Firm started the recall
Mar 14, 2018FDA classified it Class II
Mar 21, 2018Published in FDA’s Enforcement Report
May 17, 2021FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/71961-brainlab-exactrac-software-versions-6-0-6-5-may-cause">Brainlab ExacTrac Software Versions 6.0-6.5 May Cause Misinterpretation of Beam (GovInfoNow)</a>

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-1006-2018 (February 14, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1006-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 28, 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.