Z-1430-2026 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 unit

Product Description

Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR

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: CRUS01/ UDI: (01)04560333350006(21)CRUS01(11)190920