Z-1429-2026 Class II Ongoing
FDA device recall Z-1429-2026 was initiated by Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha on February 6, 2026 and is designated Class II. Reason for recall: Software anomaly in the patient positioning system may result in positional discrepancy. The recall status is ongoing. Affected quantity: 1.
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