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Recall Observatory FDA recall evidence

Device product

Siemens syngo.plaza. Radiological image processing system

Z-2078-2012

February 24, 2012

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 62462
Status
Terminated
Classification
Class II
Quantity
2
Official record key
device-enforcement:Z-2078-2012

Official wording

Reason: Siemens became aware of a potential malfunction when using syngo.plaza with software version VA20C_HF01. For datasets with distance measurements it can happen, that all images are not loaded to Viewer but no error message is displayed to user.

Code information: Model number 10592457

Distribution pattern: (USA) nationwide including the states of CA, FL, GA, MA, MN, MO, NJ, NY, OH, WA, and WI.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    malfunction when using syngo.plaza with software