The Recall Desk
HighFDA (Devices)·Z-1582-2015·Announced 2015-05-13

Brainlab ExacTrac 6.x Software Recalled for Potential Positioning Errors

Brainlab AG is recalling ExacTrac 6.x software due to potential patient positioning errors when using CBCT at non-zero couch angles.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (incorrect patient positioning during radiation therapy) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Brainlab AG is recalling ExacTrac 6.x software, which is used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures. The recall involves 25 systems in the United States and 53 systems in foreign countries, including Austria, China, Denmark, France, Germany, Hong Kong, Japan, Netherlands, Qatar, Russian Federation, South Korea, and Switzerland.

The recall is issued because the software may result in potentially incorrect patient positioning when using the ExacTrac Cone Beam CT (CBCT) with a CBCT acquired at a couch angle other than 0.0 degrees. This issue could affect the accuracy of the treatment beam placement.

Healthcare facilities using this software should contact Brainlab AG for instructions on how to address the issue. The recall covers specific software versions including v. 6.0.0 through v. 6.0.5 and v. 6.1.0, associated with various model and catalog numbers listed in the agency documentation.

The recalled product

Product
ExacTrac 6.x. is software used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures.
Manufacturer
Brainlab AG
Category
Medical Device — Radiation Therapy Software
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Software Versions: ExacTrac v. 6.x (v. 6.0.0
  • 6.0.1
  • 6.0.2
  • 6.0.3
  • 6.0.4
  • 6.0.5
  • and v. 6.1.0)
  • Model/Catalog Numbers: 49971
  • CBCT IMPORT & ALIGNMENT SOFTWARE
  • 20836
  • EXACTRAC 6.0 VARIAN CBCT LICENSE
  • 48320
  • ET UPGRADE SOFTWARE 6.0 TO 6.1
  • 48320-99
  • ET UPGRADE SOFTWARE 6.0 TO 6.1 SLA
  • 49973B
  • ET DATA PREP / REVIEW SYSTEM
  • 49973A
  • 49973
  • 49998B

Distribution

Distributed nationwide across the United States.

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