FDAFDA · Food and drugs·Recall number Z-1216-2014
syngo Dynamics Picture Archiving and Communication System (PACS). Model numbers 10091804, 10091805, 10091806, 10091807, 10091673
Published March 26, 2014 · Recall initiated: January 27, 2014
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
Potential patient data mixup. Improper error handling could allow for two different patients to be displayed in syngo Dynamics. Images shown for one patient and reporting system shown for a different patient, leading to the potential for misdiagnosis.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Distributor
- Nationwide distribution to MN, AR, MA, TX, NJ, WV, GA, CA, PA, OH, MI, WI, TN, NY, KS, CT, NY, MO, IL, IN, OR, IA, and WA.
- Lot
- Model nos.10091804, 10091805, 10091806, 10091807, 10091673. syngo Dynamics Version 9.5 using Sensis integration.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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