🔍 RecallPedia

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 treatment is indicated. ExacTrac may also be used to monitor the patient position during the treatment.

Class I - Dangerous
🏥 Medical Devices Recalled: June 24, 2014 Brainlab AG Diagnostic Equipment

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Brainlab AG
Reason for Recall:
When using multiple isocenters (radiation treatment targets) within a single plan, in certain workflow conditions ExacTrac v.6.0.4 might move the patient to an unintended isocenter position, despite displaying the green "OK" icon. If this anomaly occurs and is not detected by the user, the radiation treatment dose at the linear accelerator may be delivered to the unintended target position.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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 treatment is indicated. ExacTrac may also be used to monitor the patient position during the treatment.

Product Codes/Lot Numbers:

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: CA, CT, IL

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2146-2014

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