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Recall Observatory FDA recall evidence

Device product

Siemens syngo.plaza SW version VA20 with Mammography license. image processing, radiological system

Z-1975-2013

March 04, 2013

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 65719
Status
Terminated
Classification
Class II
Quantity
6
Official record key
device-enforcement:Z-1975-2013

Official wording

Reason: Siemens issued a Customer Safety Notice to inform customers of a potential problem when using syngo.plaza. In some instances, it can happen that the laterality information in mammography images is not displayed and these images may not be properly aligned to mammography segments.

Code information: Model number 10592457, serial numbers 100219, 100201, 100473. Update dated 5/13/13 included the following additional serial numbers: 100177, 100504, 100174, 100181, 100473, and 100539.

Distribution pattern: Nationwide distribution: FL, MA, KS, NY, OH, PA, TX and WI.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Siemens issued a Customer Safety Notice to inform customers of a potential problem when using syngo.plaza. In some instances, it can happen that the laterality information in mammography images is not displayed and these images may not be properly aligned to mammography segments.