Drug recall
18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model…
FDA recall event 76987 · Class II · Siemens Medical Solutions USA, Inc.
Key facts
| Event ID | 76987 |
|---|---|
| Recall numbers | Z-1875-2017 |
| Recalling firm | Siemens Medical Solutions USA, Inc. |
| Product type | Devices |
| Products | 18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer 10041227 & 10789400 S1000 10441701 S2000 10041461 S2000 (Refurb)… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | When scanning with the 18L6 HD transducer on the ACUSON HELX" Evolution with Touch Control, the ultrasound system may display a triple image or an image with a dark band. For the triple image issue… |
| Initiation date | Mar 30, 2017 |
| Report date | May 3, 2017 |
| Termination date | Mar 21, 2019 |
| 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: