Drug recall
MEVION S250, used for proton radiation therapy.
FDA recall event 69778 · Class II · Mevion Medical Systems, Inc.
Key facts
| Event ID | 69778 |
|---|---|
| Recall numbers | Z-0588-2015 |
| Recalling firm | Mevion Medical Systems, Inc. |
| Product type | Devices |
| Products | MEVION S250, used for proton radiation therapy. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Software defect that causes an incorrect dose compensation function to be applied to the internal dose ionization chamber when either pressure or temperature sensor malfunction. This could result in… |
| Initiation date | Nov 10, 2014 |
| Report date | Dec 17, 2014 |
| Termination date | Mar 18, 2015 |
| City | Littleton |
| State | MA |
| Country | United States |
| FEI number | 3007087027 |
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: