Drug recall
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA recall event 89139 · Class II · Siemens Medical Solutions USA, Inc.
Key facts
| Event ID | 89139 |
|---|---|
| Recall numbers | Z-0547-2022 |
| Recalling firm | Siemens Medical Solutions USA, Inc. |
| Product type | Devices |
| Products | ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Due to a calculation error in the measurement when using 2D trace (manual trace) tool. The trace circumference value is overestimated and may potentially result in misdiagnosis of a patient's… |
| Initiation date | Nov 12, 2021 |
| Report date | Feb 9, 2022 |
| City | Issaquah |
| State | WA |
| Country | United States |
| FEI number | 3023245 |
At a glance
- 1–9 Products in this recall
- 10–99 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: