Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Versions 1.1.0 and 1.1.1, GTIN: 04056481143978.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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:
- Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a standard-workflow Treatment Template
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F.
Product Codes/Lot Numbers:
Versions 1.1.0 and 1.1.1, GTIN: 04056481143978.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1259-2023
Related Recalls
Under certain circumstances, it can occur that patient records from unrelated individuals are automatically merged into one patient record without user notification.
Cirq Arm System 2.0
Brainlab AG
Risk of mechanical instability due to potential manufacturing error of the device
The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs.