Drug recall
E.cam or Symbia systems that use foresight detectors - Product Usage: To detect or image the distribution of…
FDA recall event 86230 · Class II · Siemens Medical Solutions USA, Inc.
Key facts
| Event ID | 86230 |
|---|---|
| Recall numbers | Z-2898-2020 |
| Recalling firm | Siemens Medical Solutions USA, Inc. |
| Product type | Devices |
| Products | E.cam or Symbia systems that use foresight detectors - Product Usage: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | E. CAM and Symbia system with foresight detectors performing gated or dynamic acquisition may lose some detector time information. Our risk analysis indicates that the probability of occurrence is… |
| Initiation date | Mar 31, 2016 |
| Report date | Sep 2, 2020 |
| Termination date | Oct 29, 2020 |
| City | Hoffman Estates |
| State | IL |
| Country | United States |
| FEI number | 1000514697 |
At a glance
- 1–9 Products in this recall
- 1–9 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: