FDA Medical devices recall ·
Hitachi Proton Beam Therapy System Ref: PROBEAT-FR recall
- Recall number
- Z-1429-2026
- Date
- (initiated February 6, 2026)
- Company / brand
- Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
44-141-1,W 226, Kashiwa, N/A, Japan - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR
Why was it recalled?
Software anomaly in the patient positioning system may result in positional discrepancy.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Serial number: PTFR-01/ UDI:(01)04560333350204(11)240112(21)PTFR-01
Distribution
US distribution to states of: TX, Washington DC
States: District of Columbia Texas Washington
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1429-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.