FDAFDA · Food and drugs·Recall number Z-2078-2012
Siemens syngo.plaza. Radiological image processing system
Published August 1, 2012 · Recall initiated: February 24, 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 a potential malfunction when using syngo.plaza with software version VA20C_HF01. For datasets with distance measurements it can happen, that all images are not loaded to Viewer but no error message is displayed to user.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Distributor
- (USA) nationwide including the states of CA, FL, GA, MA, MN, MO, NJ, NY, OH, WA, and WI.
- Lot
- Model number 10592457
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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