FDA Device recall Z-1244-2016
MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) Intended for radiation therapy of lesions, tumors. conditions anywh…
- FDA Device
- Class II
- terminated
- Published 2016-03-30
On 2016-03-30 the FDA classified a Class II recall of MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) Intended for radiation therapy of lesions, tumors. conditions anywh… by Mitsubishi Heavy Industries Hiroshima Machinery Work, citing 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" u….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1244-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-12-15 |
| Published | 2016-03-30 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Mitsubishi Heavy Industries Hiroshima Machinery Work |
| Distribution | FL, NY, OH, TX |
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
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.
Identifiers
| code_info | Serial numbers: 201901, 201902, 201903, 201904, 201905, 202901, 202902, 202903, 202904, 202905, 202906, 203901, 203902,…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 and 203929. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1244-2016%22
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