FDAFDA · Food and drugs·Recall number Z-0948-2013
Siemens Somatom CTs equipped with software syngo CT2010A, syngo CT2010B, syngo CT2011A and CT2012B. Computed tomography x-ray system.
Published March 20, 2013 · Recall initiated: November 27, 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
Sporadic hang-up malfunctions concerning 3D reconstructions during activated "Preview Image" functionality.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Distributor
- Nationwide Distribution.
- Lot
- Model numbers - 7740769, 8098027, 10430603, and 10590000.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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