Drug recall
Monaco RTP System, 5.40 Unity, radiation treatment planning system Product Usage: The Monaco system is used to…
FDA recall event 83692 · Class II · Elekta Inc
Key facts
| Event ID | 83692 |
|---|---|
| Recall numbers | Z-2560-2019, Z-2561-2019 |
| Recalling firm | Elekta Inc |
| Product type | Devices |
| Products | Monaco RTP System, 5.40 Unity, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy…, Monaco RTP System, 5.50/5.51, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | It is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation. |
| Initiation date | Sep 4, 2019 |
| Report date | Oct 2, 2019 |
| City | Maryland Heights |
| 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: