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Recall Observatory FDA recall evidence

Device product

Siemens syngo.plaza radiological image processing system.

Z-0048-2013

June 06, 2012

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 63045
Status
Terminated
Classification
Class II
Quantity
11
Official record key
device-enforcement:Z-0048-2013

Official wording

Reason: Siemens became aware of an unintended behavior when using syngo.plaza. In syngo.plaza within the online "Short Time Storage" (STS), some studies are marked with an archived icon, however, the entry in the Archive Database referring to the physical file may be missing.

Code information: Model number 10592457, serial numbers 100263, 100401, 100177, 100138, 100174, 100406, 100249, 100201, 100198, 100181, 100146.

Distribution pattern: Nationwide Distribution including the states of MO, FL, MA, NY, WI, GA, CA and WA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Siemens became aware of an unintended behavior when using syngo.plaza. In syngo.plaza within the online "Short Time Storage" (STS), some studies are marked with an archived icon, however, the entry in the Archive Database referring to the physical file may be missing.