Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR
Class I - Dangerous 🏥 Medical Devices
Recalled: February 6, 2026 Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha Other Medical Devices
What Should You Do?
- Check if you have this product: Serial number: PTFR-01/ UDI:(01)04560333350204(11)240112(21)PTFR-01
- 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:
- Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
- Reason for Recall:
- Software anomaly in the patient positioning system may result in positional discrepancy.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR
Product Codes/Lot Numbers:
Serial number: PTFR-01/ UDI:(01)04560333350204(11)240112(21)PTFR-01
Distribution:
Distributed in: US, TX, DC
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1429-2026