FDAFDA · Food and drugs·Recall number Z-1975-2013
Siemens syngo.plaza SW version VA20 with Mammography license. image processing, radiological system
Published August 21, 2013 · Recall initiated: March 4, 2013
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 issued a Customer Safety Notice to inform customers of a potential problem when using syngo.plaza. In some instances, it can happen that the laterality information in mammography images is not displayed and these images may not be properly aligned to mammography segments.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Distributor
- Nationwide distribution: FL, MA, KS, NY, OH, PA, TX and WI.
- Lot
- Model number 10592457, serial numbers 100219, 100201, 100473. Update dated 5/13/13 included the following additional serial numbers: 100177, 100504, 100174, 100181, 100473, and 100539.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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