[pending] Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR
Pending LLM rewrite. Source: FDA_DEVICE Z-1430-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Software anomaly in the patient positioning system may result in positional discrepancy.
The recalled product
- Product
- Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR
- Manufacturer
- Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial Number: CRUS01/ UDI: (01)04560333350006(21)CRUS01(11)190920
Distribution
Distributed in 2 states:
- DC
- TX
Related recalls
Same category
- ModeratePhilips Allura X-ray Systems Deaeration Hose Degradation Recall
FDA (Devices) · 2026-05-27
- HighOncology Kit With Extension Sets May Leak During Infusion Therapy
FDA (Devices) · 2026-05-27
- HighMedtronic GUNDRY Retrograde Cannula vascular catheter sterile barrier breach
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27