Official recall notice
FDA DeviceClass IINotable
FDA Recall: Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR
- Recall date
- 2026-03-04
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Software anomaly in the patient positioning system may result in positional discrepancy.
Recommended action
What to do
1
Product description
Software anomaly in the patient positioning system may result in positional discrepancy.