Drug recall
Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10
FDA recall event 88451 · Class II · Elekta Inc
Key facts
| Event ID | 88451 |
|---|---|
| Recall numbers | Z-2406-2021 |
| Recalling firm | Elekta Inc |
| Product type | Devices |
| Products | Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | If a couch is removed while a plan is loaded, and then added back to the Studyset when the plan is unloaded, it is possible to calculate dose with the couch unassigned to the beams. |
| Initiation date | Jul 26, 2021 |
| Report date | Sep 8, 2021 |
| City | Saint Charles |
| State | MO |
| Country | United States |
| FEI number | 1937649 |
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: