The Recall Desk
HighFDA (Devices)·Z-1316-2015·Announced 2015-04-01

Brainlab ExacTrac 6.x Patient Positioning Systems Recalled for Positioning Errors

Brainlab is recalling ExacTrac 6.x systems because they may incorrectly position patients during radiosurgery or radiotherapy when using specific CBCT software.

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 FDA classified this as a Class II recall involving a medical device that may incorrectly position patients during radiation therapy, which poses a risk of harm even though specific injury reports are not detailed in the source text.

Plain-English summary

Brainlab AG is recalling ExacTrac versions 6.x patient positioning systems. These devices are used to position patients during radiosurgery or radiotherapy procedures. The recall covers 24 systems in the United States and 36 systems in foreign countries, including Australia, Austria, Canada, Denmark, France, Germany, Hong Kong, Japan, Russia, Singapore, South Korea, and the United Kingdom.

The recall is due to a defect where the system may incorrectly position the patient when using the ExacTrac Cone Beam CT (CBCT) with a TrueBeam-specific optional subvolume-CBCT. The affected software versions include 6.0.0 through 6.0.5 and 6.1.0. Specific model and catalog numbers are listed in the agency's recall record.

Healthcare facilities using these systems should contact Brainlab AG for instructions on how to resolve the issue. The FDA has classified this as a Class II recall, indicating that use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product
ExacTrac versions 6.x patient positioning systems are used to position patients during radiosurgery or radiotherapy procedures..
Manufacturer
Brainlab AG
Category
Medical Device — Radiation Therapy Equipment
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)

  • ExacTrac versions 6.x including versions 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
  • The software may be contained in configured items: 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
  • ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT

Distribution

Distribution scope not specified by the agency.

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