Drug recall
The following Pro.specta Emission Computed Tomography Systems that were manufactured with an SLD Look Ahead…
FDA recall event 92704 · Class II · Siemens Medical Solutions USA, Inc.
Key facts
| Event ID | 92704 |
|---|---|
| Recall numbers | Z-2256-2023 |
| Recalling firm | Siemens Medical Solutions USA, Inc. |
| Product type | Devices |
| Products | The following Pro.specta Emission Computed Tomography Systems that were manufactured with an SLD Look Ahead Optical Sensor Assembly: (a) Symbia Pro.specta Q3, Model 11364751; (b) Symbia Pro.specta X3… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | During a whole-body planar scan with auto-contour, there is a possibility the short-linear drive (SLD) look-ahead sensors may trigger earlier than expected and may result in detector 1 positioning… |
| Initiation date | Jul 12, 2023 |
| Report date | Aug 9, 2023 |
| 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: