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.
The system may not correctly account for ring angle corrections during couch shifts, causing the treatment couch to move to an incorrect position. This could result in the radiation treatment missing the intended target, potentially leading to ineffective therapy or exposure to healthy tissue.
Patients using the ExacTrac Vero 3.5 system with specific model numbers (46228, 46238, 46216) for radiation therapy are affected. Medical professionals who operate these systems are most at risk of treatment errors.
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.
Verify your ExacTrac Vero system's software version by checking the model number and software version on the device.
Reach out to Brainlab directly for guidance on whether your system needs an update or correction.
No, only specific model numbers (46228, 46238, 46216) with software versions 3.5.x are affected.
Check for model numbers 46228, 46238, or 46216 on the ExacTrac Vero system, as these specific models were sold with software versions that may have the issue.
No, but you should check your software version and contact Brainlab to determine if an update is needed.
We’ve drafted a message you can send Brainlab to request your refund or repair — edit it as you like.
Subject: Recall Z-0172-2018 — Brainlab Brainlab Hello, I own a Brainlab that is covered by recall Z-0172-2018 from Brainlab. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
