FDA Device recall Z-1429-2026
Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR
- FDA Device
- Class II
- ongoing
- Published 2026-03-04
On 2026-03-04 the FDA classified a Class II recall of Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR by Hitachi Radiation Oncology Systems Kashiwanoha, citing software anomaly in the patient positioning system may result in positional discrepancy.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1429-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-02-06 |
| Published | 2026-03-04 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Hitachi Radiation Oncology Systems Kashiwanoha |
| Distribution | DC, TX, WA |
Product
Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR
Reason
Software anomaly in the patient positioning system may result in positional discrepancy.
Identifiers
| code_info | Serial number: PTFR-01/ UDI:(01)04560333350204(11)240112(21)PTFR-01 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1429-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.