FDAFDA · Food and drugs·Recall number Z-2275-2012
syngo.plaza, Model number 10592457. Intended use: radiological image processing system.
Published September 5, 2012 · Recall initiated: July 18, 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
There is a potential malfunction in which a miscalculation occurs for images with pixel depth values greater that 12 bit in certain functions.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Distributor
- Nationwide Distribution -- CA, FL, GA, MA, MN, MO, NJ, NY, OH, WA, and WI.
- Lot
- Serial Numbers: 100263, 100401, 100177, 100138, 100174, 100219, 100406, 100249, 200040, 100201, 100198, 100181, 100301, & 100146.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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