Drug recall
MHI-TM2000 Linear Accelerator System Product Usage: MHI-TM2000 Linear Accelerator System is intended for…
FDA recall event 79439 · Class II · Hitachi Ltd., Medical System Operations Group
Key facts
| Event ID | 79439 |
|---|---|
| Recall numbers | Z-1585-2018 |
| Recalling firm | Hitachi Ltd., Medical System Operations Group |
| Product type | Devices |
| Products | MHI-TM2000 Linear Accelerator System Product Usage: MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Due to a system controller software anomaly, the patient positioning deviation correction may not be applied and may result in the wrong part of the patient being irradiated. |
| Initiation date | Dec 8, 2017 |
| Report date | May 9, 2018 |
| Termination date | Apr 11, 2019 |
| City | Kashiwa |
| Country | Japan |
| FEI number | 3008238760 |
At a glance
- 1–9 Products in this recall
- 1–9 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: