- Recalling firm
- Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
- Reason for recall
- Software anomaly in the patient positioning system may result in positional discrepancy.
- Affected products (lot / model / serial)
- Serial Number: CRUS01/ UDI: (01)04560333350006(21)CRUS01(11)190920
- Units affected
- 1 unit
- Distribution pattern
- US distribution to states of: TX, Washington DC
- Firm location
- Kashiwa, N/A, Japan
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Visit
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-1430-2026
- Recall initiated
- February 6, 2026
- FDA classification date
- February 20, 2026
- FDA report date
- March 4, 2026
- FDA event ID
- 98330
- Last updated on HTM Vibe
- July 24, 2026