MHI-TM2000 Linear Accelerator System — Class II medical device recall Z-1574-2015
Terminated recall by MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK, reported 2015-05-13, distributed in FL, NY, OH, TX. The operator console allows users to deliver therapeutic radiation to patients even though a specific communic
| Recall number | Z-1574-2015 |
|---|---|
| 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 | 2015-04-17 |
| Classified | 2015-05-01 |
| Reported by FDA | 2015-05-13 |
| Terminated | 2017-04-11 |
| Distributed | FL, NY, OH, TX |
| Countries outside the US | BE, DE, FR, IT, KR |
| Quantity | 11 units |
| Serial numbers | 201902, 201903, 202903, 202905, 203901, 203902, 203903, 203905, 203906, 203919, 203924 |
Product
MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1)
Reason for recall
The operator console allows users to deliver therapeutic radiation to patients even though a specific communication error relevant to imaging conditions has occurred. In addition, the treatment record (the delivered radiation record) cannot be saved.
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-1574-2015. 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.