FDAFDA · Food and drugs·Recall number Z-2219-2012
syngo Dynamics Version 9.5
Published August 29, 2012 · Recall initiated: July 13, 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
If multiple uncompressed images/clips are sent to the syngo Dynamics server, around the same time, it is possible for an image from a patient to be placed in another patient's study.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Medical Solutions, USA, Inc
- Distributor
- Nationwide Distribution -- MA, GA, MO, IA, CA, PA, OR, CO, NY, NJ, WA, UT, OH, WI, MI, KY, and NC.
- Lot
- 10091862 and 10091863
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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