FDAFDA · Food and drugs·Recall number Z-0048-2013
Siemens syngo.plaza radiological image processing system.
Published October 17, 2012 · Recall initiated: June 6, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Siemens became aware of an unintended behavior when using syngo.plaza. In syngo.plaza within the online "Short Time Storage" (STS), some studies are marked with an archived icon, however, the entry in the Archive Database referring to the physical file may be missing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Distributor
- Nationwide Distribution including the states of MO, FL, MA, NY, WI, GA, CA and WA.
- Lot
- Model number 10592457, serial numbers 100263, 100401, 100177, 100138, 100174, 100406, 100249, 100201, 100198, 100181, 100146.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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