FDA Device recall Z-1574-2015
MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1)
- FDA Device
- Class II
- terminated
- Published 2015-05-13
On 2015-05-13 the FDA classified a Class II recall of MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1) by Mitsubishi Heavy Industries Hiroshima Machinery Work, citing 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,….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1574-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-04-17 |
| Published | 2015-05-13 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Mitsubishi Heavy Industries Hiroshima Machinery Work |
| Distribution | FL, NY, OH, TX |
Product
MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1)
Reason
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.
Identifiers
| code_info | Serial Numbers: 201902, 201903, 202903, 202905, 203901, 203902, 203903, 203905, 203906, 203919 & 203924 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1574-2015%22
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