MHI-TM2000 Linear Accelerator System Product Usage: MHI-TM2000 Linear… — Class II medical device recall Z-1585-2018
Terminated recall by Hitachi Ltd., Medical System Operations Group, reported 2018-05-09, distributed in NY. Due to a system controller software anomaly, the patient positioning deviation correction may not be applied a
| Recall number | Z-1585-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hitachi Ltd., Medical System Operations Group, Kashiwa, N/A, Japan |
| Recall initiated | 2017-12-08 |
| Classified | 2018-05-01 |
| Reported by FDA | 2018-05-09 |
| Terminated | 2019-04-11 |
| Distributed | NY |
| Quantity | 1 |
| Reason classes | software |
| Serial numbers | 203919 |
Product
MHI-TM2000 Linear Accelerator System Product Usage: MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
Reason for recall
Due to a system controller software anomaly, the patient positioning deviation correction may not be applied and may result in the wrong part of the patient being irradiated.
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-1585-2018. 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.