Drug recall
MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1)
FDA recall event 70638 · Class II · MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
Key facts
| Event ID | 70638 |
|---|---|
| Recall numbers | Z-1574-2015 |
| Recalling firm | MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK |
| Product type | Devices |
| Products | MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1) |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Apr 17, 2015 |
| Report date | May 13, 2015 |
| Termination date | Apr 11, 2017 |
| City | HIROSHIMA |
| Country | Japan |
| FEI number | 3006942329 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: