The Recall Desk
HighFDA (Devices)·Z-2146-2014·Announced 2014-08-13

Brainlab ExacTrac Software Recall for Potential Radiation Misalignment

Brainlab AG is recalling ExacTrac v6.0.4 software because it may move patients to the wrong position during radiation treatment, potentially delivering the dose to an unintended target.

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 involves a high-risk medical device defect where radiation could be delivered to an unintended target, posing a risk of harm, but the source text does not report any actual injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Brainlab AG is recalling 15 ExacTrac systems running version 6.0.4 of its positioning software. The recall covers specific software models and upgrade kits used in medical accelerators for stereotactic radiosurgery and radiotherapy. The affected systems were distributed worldwide, including in the United States (California, Connecticut, and Illinois) and internationally to France, Germany, Japan, the Netherlands, Russia, and Slovenia.

The recall is due to a software defect that can occur when using multiple isocenters (radiation treatment targets) within a single plan. Under certain workflow conditions, the software might move the patient to an unintended isocenter position while still displaying a green "OK" icon. If this error is not detected by the user, the radiation treatment dose may be delivered to the wrong target position.

Healthcare facilities using the affected software should contact Brainlab AG for instructions on how to resolve the issue. The source text does not report any specific injuries or illnesses associated with this defect.

The recalled product

Product
ExacTrac is intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, in order to treat lesions, tumors and conditions anywhere in the body when radiation treat
Manufacturer
Brainlab AG
Category
Medical Device — Radiation Therapy Software
Hazard
Affected units
15

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 (17)

  • ExacTrac Version 6.0.4
  • Model/Catalog Numbers: 1) 20833C EXACTRAC 6.0 IR POSITIONING SOFTWARE
  • 2) 20834C EXACTRAC 6.0 X-RAY POSITIONING SOFTWARE
  • 3) 20835C EXACTRAC 6.0 IR MONITORING SOFTWARE
  • 4) 20853C EXACTRAC 6.0 X-RAY LIMITED SOFTWARE
  • 5) 49926B ET UPGRADE SOFTWARE 3.X TO 6.0 (IR+XR)
  • 6) 49927B ET UPGRADE SOFTWARE 4.X TO 6.0 (IR+XR)
  • 7) 49928B ET UPGRADE SOFTWARE 5.X TO 6.0 (IR+XR)
  • 8) 49933B ET UPGRADE TRUEBEAM 5.5 TO 6.0 LIMITED
  • 9) 49934A EXACTRAC UPGRADE 5.5 TO 6.0 BASIC
  • 10) 49936A ET SOFTWARE UPDATE 6.0.X TO 6.0.4
  • 11) 49938 ET SOFTWARE UPDATE 6.0.3TO 6.0.4
  • 12) 49939 ET SOFTWARE UPDATE 6.0.X to 6.0.4 P&R
  • 13) 49973B ET DATA PREP / REVIEW SYSTEM
  • 14) 49996B ET UPGRADE SOFTWARE X.X TO 6.0 SW ONLY
  • 15) 49997B ET UPGRADE SOFTWARE 5.5 TO 6.0 LIMITED
  • 16) 49998B ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT

Distribution

Distributed in 3 states:

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