🔍 RecallPedia

ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System).

Class I - Dangerous
🏥 Medical Devices Recalled: March 1, 2021 Brainlab AG Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Model/catalogue numbers: 20910-06 ETD Implanted lic. UDI: The GTIN for ExacTrac Dynamic version 1.0 is 04056481142315. GMDN code: 40887. Software revisions of affected ExacTrac Dynamic software: versions 1.0.0, 1.0.1, 1.0.2.
  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:
In case of a failed automatic marker detection, a software error causes parts of the display to incorrectly behave as if the current patient position is within predefined tolerances and may allow the user to proceed to treatment despite potentially exceeding shift values.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System).

Product Codes/Lot Numbers:

Model/catalogue numbers: 20910-06 ETD Implanted lic. UDI: The GTIN for ExacTrac Dynamic version 1.0 is 04056481142315. GMDN code: 40887. Software revisions of affected ExacTrac Dynamic software: versions 1.0.0, 1.0.1, 1.0.2.

Distribution:

Distributed in: CA, NJ, AZ, AR, NY, IN, OR, NC

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1185-2021

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