Drug recall
Software version VD10E for Syngo X-Workplace; Picture archiving and communication system.
FDA recall event 72751 · Class II · Siemens Medical Solutions USA, Inc
Key facts
| Event ID | 72751 |
|---|---|
| Recall numbers | Z-0597-2016 |
| Recalling firm | Siemens Medical Solutions USA, Inc |
| Product type | Devices |
| Products | Software version VD10E for Syngo X-Workplace; Picture archiving and communication system. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Potential post-processing software issue when using tabcard "4D" on X-Workplace with software version VD10E. A too small measurement in the MPRs of a volume when images are acquired with a CT scanner… |
| Initiation date | Nov 18, 2015 |
| Report date | Jan 13, 2016 |
| Termination date | Dec 5, 2016 |
| City | Malvern |
| State | PA |
| Country | United States |
| FEI number | 2240869 |
At a glance
- 1–9 Products in this recall
- None 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: