Drug recall
VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-14021, Software Version: 3.1, 3.2…
FDA recall event 69825 · Class II · MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
Key facts
| Event ID | 69825 |
|---|---|
| Recall numbers | Z-0821-2015 |
| Recalling firm | MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK |
| Product type | Devices |
| Products | VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-14021, Software Version: 3.1, 3.2 and 3.5.0. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Dec 2, 2014 |
| Report date | Dec 24, 2014 |
| Termination date | Jun 26, 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: