Drug recall
Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00
FDA recall event 88860 · Class II · Elekta, Inc.
Key facts
| Event ID | 88860 |
|---|---|
| Recall numbers | Z-0182-2022 |
| Recalling firm | Elekta, Inc. |
| Product type | Devices |
| Products | Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Under certain circumstances, there can be a difference between the planned and delivered dose of the two ovoid channels. |
| Initiation date | Oct 13, 2021 |
| Report date | Nov 3, 2021 |
| City | Atlanta |
| State | GA |
| Country | United States |
| FEI number | 1037831 |
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: