PROBEAT-V — Class II medical device recall Z-1892-2019
Terminated recall by Hitachi America, Ltd., Power Systems Division, reported 2019-07-03, distributed in AZ, MN, TN. There is a potential for a discrepant target position when using 3D3D matching mode in PIAS (Positioning Image
| Recall number | Z-1892-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hitachi America, Ltd., Power Systems Division, Houston, TX, United States |
| Recall initiated | 2019-04-15 |
| Classified | 2019-06-27 |
| Reported by FDA | 2019-07-03 |
| Terminated | 2020-04-24 |
| Distributed | AZ, MN, TN |
| Countries outside the US | JP |
| Quantity | 3 |
| Reason classes | software |
Product
PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system.
Reason for recall
There is a potential for a discrepant target position when using 3D3D matching mode in PIAS (Positioning Image Analysis System) software installed in the PROBEAT-V, proton therapy systems.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1892-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.