FDA Enforcement
Class II
Ongoing
Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR
Recall: Z-1430-2026
·
Reported March 4, 2026
Enforcement
- Recall Number
- Z-1430-2026
- Event ID
- 98330
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Visit
- Report Date
- March 4, 2026
- Initiation Date
- February 6, 2026
- Classification Date
- February 20, 2026
- Address
- 44-141-1,W 226, Wakashiba, Kashiwa, N/A, N/A, Japan
Description
Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR
Reason
Software anomaly in the patient positioning system may result in positional discrepancy.
Code Info
Serial Number: CRUS01/ UDI: (01)04560333350006(21)CRUS01(11)190920
Distribution
US distribution to states of: TX, Washington DC
Quantity
1 unit