Drug recall
ACUSON SC2000 Ultrasound Systems between software versions VA16A and VA30A and with the Stress Echo Option…
FDA recall event 71469 · Class II · Siemens Medical Solutions USA, Inc.
Key facts
| Event ID | 71469 |
|---|---|
| Recall numbers | Z-1959-2015 |
| Recalling firm | Siemens Medical Solutions USA, Inc. |
| Product type | Devices |
| Products | ACUSON SC2000 Ultrasound Systems between software versions VA16A and VA30A and with the Stress Echo Option. Model number 10433816: The SC2000 ultrasound imaging system is intended for the following… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | When performing a 2D Stress Echo study, some following keystrokes result in a potential loss of data, where some selected clips may not be saved as part of the study. |
| Initiation date | May 29, 2015 |
| Report date | Jul 8, 2015 |
| Termination date | Mar 9, 2017 |
| City | Mountain View |
| State | CA |
| Country | United States |
| FEI number | 2936884 |
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: