Recall Z-1429-2026 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR
| Date | Feb 20, 2026 (initiated Feb 6, 2026) |
| Status | Open, Classified |
| Reason | Software anomaly in the patient positioning system may result in positional discrepancy. |
| Root cause | Software design |
| Action | 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 s |
| Quantity | 1 |
| Distribution | US distribution to states of: TX, Washington DC |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K232032 | PROBEAT-FR Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha, Jan 12, 2024 |