MHI-TM2000 Linear Accelerator System — Class II medical device recall Z-1931-2013
Terminated recall by MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK, reported 2013-08-14, distributed nationwide. Software anomaly: Mitsubishi Heavy Industries, Ltd. became aware of a potential safety issue associated with t
| Recall number | Z-1931-2013 |
|---|---|
| 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 | 2013-06-21 |
| Classified | 2013-08-08 |
| Reported by FDA | 2013-08-14 |
| Terminated | 2017-03-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, IT, JP, KR |
| Quantity | 14 |
| Reason classes | software |
| Serial numbers | 201902, 203901 |
Product
MHI-TM2000 Linear Accelerator System, Software Version 3.0.0 revision 13 or earlier; Proprietary and Trade Name: MHI-TM2000/ VERO (TM); Common Name: Medical Linear Accelerator. 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
Software anomaly: Mitsubishi Heavy Industries, Ltd. became aware of a potential safety issue associated with the VERO (TM) Linear Accelerator System. The VERO (TM) may save treatment delivery record into wrong location under certain 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-1931-2013. 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.