[pending] Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR
Pending LLM rewrite. Source: FDA_DEVICE Z-1429-2026.
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 System Ref: PROBEAT-FR
- 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: PTFR-01/ UDI:(01)04560333350204(11)240112(21)PTFR-01
Distribution
Distributed in 2 states:
- DC
- TX
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