Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR
FDA device recall Z-1429-2026 · posted 2026-02-20 · Open, Classified
Recall details
- Recalling firm
- Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
- Reason for recall
- Software anomaly in the patient positioning system may result in positional discrepancy.
- Action taken
- Between the dates of February 5-11, 2026, Hitachi, Ltd, issued an "URGENT: MEDICAL DEVICE RECALL" notification dated January 21, 2026, via Service Team Manager to affected consignees. Hitachi is asking consignees to take the following actions: 1. Until the PPS software has been updated with the corrected version, users are instructed to follow the System Operation instruction in the document. 2. Users are also asked to post the document in a prominent space and sign its cover. 3. Complete and return the acknowledgment and receipt form. Action by the firm: Hitachi plans to update the PPS software to a corrected version that prevents the mismatch between the commanded error correction parameter and the internal variable. starting in late March 2026 and the users will be contacted after the update. If you have any questions, please call QA Manager at Tel: (408) 986-6300. Monday through Friday, 8:00 AM to 5:00 PM, Central Time.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- LHN
- Quantity affected
- 1
- Distribution
- US distribution to states of: TX, Washington DC
- Date initiated
- 2026-02-06
- Date posted
- 2026-02-20
- Location
- Kashiwa, Japan
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PROBEAT-FR (K232032) | Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha | 2024-01-12 |