MHI-TM2000 Linear Accelerator System — Class II medical device recall Z-1244-2016
Terminated recall by MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK, reported 2016-03-30, distributed in FL, NY, OH, TX. Due to Operator Console software anomaly, a change in treatment completion status of the last patient of the d
| Recall number | Z-1244-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK, HIROSHIMA, N/A, Japan |
| Recall initiated | 2015-12-15 |
| Classified | 2016-03-24 |
| Reported by FDA | 2016-03-30 |
| Terminated | 2017-04-20 |
| Distributed | FL, NY, OH, TX |
| Countries outside the US | BE, DE, FR, IT, JP, KR |
| Reason classes | software |
| Serial numbers | 201901, 201902, 201903, 201904, 201905, 202901, 202902, 202903, 202904, 202905, 202906, 203901, 203902, 203903, 203904, 203905, 203906, 203918, 203919, 203921, 203922, 203924, 203925, 203927, 203929 |
Product
MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) Intended for radiation therapy of lesions, tumors. conditions anywhere in the body where radiation therapy is indicated.
Reason for recall
Due to Operator Console software anomaly, a change in treatment completion status of the last patient of the day may be altered from "Completed (or Discontinued)" to "Untreated" under specific conditions.
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-1244-2016. 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.