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.
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.
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.
Using ExacTrac software versions 6.0-6.5 with Auxiliary Device Interface (ADI) and Varian radiation therapy systems without following the manufacturer's recommended specifications may cause the software to misinterpret beam authorization. This could result in incorrect radiation delivery to patients during treatment.
Medical professionals using ExacTrac software versions 6.0-6.5 with Varian Clinac or TrueBeam systems for radiation therapy. Patients receiving treatment with these systems are at risk if the software misinterprets beam authorization.
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.
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.
Ensure you are using the software according to the recommended specifications in the User Manual to avoid misinterpretation of beam authorization.
ExacTrac software versions 6.0, 6.1, 6.2, and 6.5.
The software is used with Varian Clinac or TrueBeam radiation therapy systems.
Check your software version in the product documentation or software interface; affected versions are 6.0, 6.1, 6.2, or 6.5.
We’ve drafted a message you can send Brainlab to request your refund or repair — edit it as you like.
Subject: Recall Z-1006-2018 — Brainlab Brainlab Hello, I own a Brainlab that is covered by recall Z-1006-2018 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
