Brand Name: Hitachi Proton Beam Therapy recall: Software Issue
Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR
Why was Brand Name: Hitachi Proton Beam Therapy recalled?
Software anomaly in the patient positioning system may result in positional discrepancy.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial Number: CRUS01/ UDI: (01)04560333350006(21)CRUS01(11)190920
- Product
- Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR
- Recalling firm
- Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
- Quantity
- 1 unit
- Distribution
- US distribution to states of: TX, Washington DC
- Recall date
- March 4, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)