Drug recall
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User…
FDA recall event 87362 · Class II · Siemens Medical Solutions USA, Inc.
Key facts
| Event ID | 87362 |
|---|---|
| Recall numbers | Z-1330-2021 |
| Recalling firm | Siemens Medical Solutions USA, Inc. |
| Product type | Devices |
| Products | Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The ultrasound system averages the Mean Sac Diameter (MSD) and Gestational Sac Diameter (GSD) into the Estimated Date of Delivery (EDD) calculation. This may result in an incorrect EDD, which may… |
| Initiation date | Feb 4, 2021 |
| Report date | Apr 7, 2021 |
| 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: