Drug recall
MEVION S250 for Proton Radiation Therapy
FDA recall event 73602 · Class II · Mevion Medical Systems, Inc.
Key facts
| Event ID | 73602 |
|---|---|
| Recall numbers | Z-1529-2016 |
| Recalling firm | Mevion Medical Systems, Inc. |
| Product type | Devices |
| Products | MEVION S250 for Proton Radiation Therapy |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Possibility of Gantry Motion with Aperture or Compensator only partially inserted. An Aperture may fall out during Gantry motion. It is possible that it can hit a patient and cause traumatic injury or… |
| Initiation date | Mar 15, 2016 |
| Report date | Apr 27, 2016 |
| Termination date | Aug 24, 2017 |
| 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: