Drug recall
Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808)
FDA recall event 89758 · Class II · Mevion Medical Systems, Inc.
Key facts
| Event ID | 89758 |
|---|---|
| Recall numbers | Z-0827-2022 |
| Recalling firm | Mevion Medical Systems, Inc. |
| Product type | Devices |
| Products | Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808) |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Malfunction of the hand pendant controlling movement of the therapy couch and nozzle may result in unintentional motion. Patient injury is possible if they come in contact with the nozzle or other… |
| Initiation date | Feb 1, 2022 |
| Report date | Apr 6, 2022 |
| 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: