PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM Product Usage: Hitachi… — Class II medical device recall Z-1838-2015
Terminated recall by Hitachi America, Ltd., Power Systems Division, reported 2015-07-29, distributed in TX. At a PROBEAT III site installed in Japan, the operator of the system found that the radiation was delivered in
| Recall number | Z-1838-2015 |
|---|---|
| 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 | 2015-04-21 |
| Classified | 2015-07-17 |
| Reported by FDA | 2015-07-29 |
| Terminated | 2016-03-24 |
| Distributed | TX |
| Countries outside the US | JP |
| Quantity | 3 |
Product
PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM Product Usage: Hitachi PROBEAT with DSSS is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
Reason for recall
At a PROBEAT III site installed in Japan, the operator of the system found that the radiation was delivered inconsistent with the treatment plan and stopped the irradiation. The irradiation control system may be potentially affected when rebooting a part of the control system.
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-1838-2015. 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.