Drug recall
The E.CAM gamma camera system Product Usage: The E.CAM gamma camera system is a SPECT system and measures the…
FDA recall event 73504 · Class II · Siemens Medical Solutions USA, Inc.
Key facts
| Event ID | 73504 |
|---|---|
| Recall numbers | Z-1262-2016, Z-1263-2016 |
| Recalling firm | Siemens Medical Solutions USA, Inc. |
| Product type | Devices |
| Products | The E.CAM gamma camera system Product Usage: The E.CAM gamma camera system is a SPECT system and measures the distribution of radiopharmaceuticals in humans for the purpose of determining various…, The Symbia gamma camera system Product Usage: The Symbia gamma camera system is a computed tomography x-ray system which is a diagnostic x-ray system intended to produce cross-sectional images of the… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | We received a customer complaint that Siemens reported via the MedWatch process (1423253-2015-00002). The result of a Hazard Analysis and CAPA investigation, we have determined that for e.cam or… |
| Initiation date | Feb 26, 2016 |
| Report date | Apr 6, 2016 |
| Termination date | Dec 23, 2016 |
| 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: