← FDA ENFORCEMENT
Z-1429-2026Class II
Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Recalling firm
Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
Product type
Device
Status
Ongoing
Report date
2026-03-04
Distribution
US distribution to states of: TX, Washington DC
Firm state
N/A
Product quantity
1
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Data IntegrityReason for recall
Software anomaly in the patient positioning system may result in positional discrepancy.
Product description
Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR
Code / lot info
Serial number: PTFR-01/ UDI:(01)04560333350204(11)240112(21)PTFR-01
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →