FDA Device recall Z-1892-2019
PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system
- FDA Device
- Class II
- terminated
- Published 2019-07-03
On 2019-07-03 the FDA classified a Class II recall of PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system by Hitachi America Power Systems Division, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1892-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-04-15 |
| Published | 2019-07-03 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Hitachi America Power Systems Division |
| Distribution | AZ, MN, TN |
Product
PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system.
Reason
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.
Identifiers
| code_info | 2015B01, A01, A02 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1892-2019%22
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