Drug recall
bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.
FDA recall event 93598 · Class II · B-K Medical A/S
Key facts
| Event ID | 93598 |
|---|---|
| Recall numbers | Z-0813-2024 |
| Recalling firm | B-K Medical A/S |
| Product type | Devices |
| Products | bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | An issue on the Dual Live Compare feature on the bkActiv system could result in a measurement error. |
| Initiation date | Nov 30, 2023 |
| Report date | Jan 31, 2024 |
| City | Herlev |
| Country | Denmark |
| FEI number | 3003705156 |
At a glance
- 1–9 Products in this recall
- None 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: