Use cautionMedical device recall · FDA · Published November 3, 2017
Brainlab ExacTrac Vero 3.5 Recalled: Risk of Treatment Position Error
Brainlab recalls ExacTrac Vero 3.5 models due to potential treatment position errors. Affected units may not move to planned positions, risking inaccurate radiation therapy. Contact Brainlab for updates.
Brainlab has internally detected that under specific conditions ExacTrac Vero may not correctly account for this ring angle correction during the calculation of the corresponding couch shift. This may result in the treatment couch not moving to the exact planned position resulting in a deviation between the planned and the treatment target position. This deviation may not be clearly visible to the user if no verification image of the patient position is acquired after this couch shift has been performed.
Brainlab is recalling specific versions of its ExacTrac Vero 3.5 treatment system because it may not correctly calculate couch shifts during radiation therapy, potentially causing the treatment to miss the target. This could lead to ineffective treatment or unnecessary radiation exposure to healthy tissue. Read more at govinfonow.com/recall/72613-brainlab-exactrac-vero-3-5-recalled-risk-of-treatment-position.
“Brainlab ExacTrac Vero 3.5 Recalled: Risk of Treatment Position Error.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/72613-brainlab-exactrac-vero-3-5-recalled-risk-of-treatment-position. Based on FDA recall #Z-0172-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0172-2018%22&limit=1).
Brainlab AG recalled the EXACTRAC VERO system on Nov. 3, 2017, after detecting a potential calculation error that could cause the treatment couch to move incorrectly. The Food and Drug Administration announced the voluntary Class II recall. Owners should contact Brainlab for software updates.
How to tell if you have it
Brand: Brainlab
Product: EXACTRAC VERO
Model/Catalog Numbers: 46228, 46238, 46216
Software Versions: EXACTRAC VERO 3.5, EXACTRAC VERO SW (versions 3.5.x)
UDI: 04056481132446
Units affected: 28
Distribution: Worldwide, including US, Belgium, Canada, France, Germany, Italy, Japan, and South Korea
The hazard
The ExacTrac Vero system may not correctly account for ring angle correction during couch shift calculations. This can result in the treatment couch moving to an incorrect position, creating a deviation between the planned and actual treatment target. The error may not be visible if no verification image is acquired.
Context
GovInfoNow's records show Brainlab AG has had 15 other recalls since July 28, 2017. Recent brand recalls include the Feb. 10, 2025 Origin Data Management Software recall and the March 2, 2023 Cirq Arm System 2.0 recall. Other recent recalls of similar products include the Feb. 6, 2026 Hitachi Proton Beam Therapy System recall and the Dec. 12, 2025 Elekta Leksell GammaPlan 11.1 Software recall.
How to tell if you have this one
Check for model numbers 46228, 46238, or 46216 on the ExacTrac Vero system. These models were sold with specific software versions (3.5.x) that may have the issue.
Brand
Brainlab
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify your ExacTrac Vero system's software version by checking the model number and software version on the device.
Contact Brainlab
Reach out to Brainlab directly for guidance on whether your system needs an update or correction.
How this recall unfolded
Recall timeline
FDA terminated this recall 3.1 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-0172-2018 (November 3, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0172-2018 to see it in context.
Plain-language summary written by qwen3:4b on September 14, 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.