Z-1429-2026 Class II Ongoing

Recalled by Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha — Kashiwa, N/A

Recall Details

Product Type
Devices
Report Date
March 4, 2026
Initiation Date
February 6, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1

Product Description

Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR

Reason for Recall

Software anomaly in the patient positioning system may result in positional discrepancy.

Distribution Pattern

US distribution to states of: TX, Washington DC

Code Information

Serial number: PTFR-01/ UDI:(01)04560333350204(11)240112(21)PTFR-01