Drug recall
Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System
FDA recall event 83273 · Class II · Elekta Inc
Key facts
| Event ID | 83273 |
|---|---|
| Recall numbers | Z-2091-2019 |
| Recalling firm | Elekta Inc |
| Product type | Devices |
| Products | Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | When creating 3D plans using either MU or Dose weighting modes, if the user changes the number of fractions, rescales the plan and then changes the wedge angle, the Monitor Units are scaled… |
| Initiation date | Jul 3, 2019 |
| Report date | Aug 7, 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: