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Recall Observatory FDA recall evidence

Device product

syngo Dynamics Version 9.5

Z-2219-2012

July 13, 2012

Class II

Product summary

Firm
Siemens Medical Solutions, USA, Inc
Event
Event 62581
Status
Terminated
Classification
Class II
Quantity
30
Official record key
device-enforcement:Z-2219-2012

Official wording

Reason: 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.

Code information: 10091862 and 10091863

Distribution pattern: Nationwide Distribution -- MA, GA, MO, IA, CA, PA, OR, CO, NY, NJ, WA, UT, OH, WI, MI, KY, and NC.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.