VERO Linear Accelerator System — Class II medical device recall Z-0821-2015
Terminated recall by MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK, reported 2014-12-24, distributed in FL, NY, OH, TX. Software Anomaly. The VERO MHI-TM2000 Operator Console may provide Patient Positioning System (ExacTrac) with
| Recall number | Z-0821-2015 |
|---|---|
| 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 | 2014-12-02 |
| Classified | 2014-12-17 |
| Reported by FDA | 2014-12-24 |
| Terminated | 2017-06-26 |
| Distributed | FL, NY, OH, TX |
| Quantity | 4 units |
| Reason classes | software |
| Serial numbers | 201902, 203901, 203919, 203924 |
| Model numbers | MHI-TM2000 |
Product
VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-14021, Software Version: 3.1, 3.2 and 3.5.0.
Reason for recall
Software Anomaly. The VERO MHI-TM2000 Operator Console may provide Patient Positioning System (ExacTrac) with Image Angle Information Used for the 1st Port Image, for a subsequent port image fusion. As the result, ExacTrac may display a Digitally Reconstructed Radiograph (DRR) image taken from the angle for the 1st port image fusion, rather than the one taken from the angle for the intended port
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-0821-2015. 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.