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Recall Observatory FDA recall evidence

Device product

Siemens syngo.plaza Radiological Image Processing System Usage: Radiological Image Processing System

Z-0465-2013

June 20, 2012

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 63521
Status
Terminated
Classification
Class II
Quantity
15
Official record key
device-enforcement:Z-0465-2013

Official wording

Reason: Firm has become aware of an unintended behavior when using syngo.plaza and issued an Update Instruction. The Update Instruction SY050/12/S provides a software update and addresses the following issues: - Patient Rename messages for the same patient are being continually processed for several days. This fills up the 'pcvdbsrv' log and potentially affects performance of the system. - Data could

Code information: Model number 10 592 457

Distribution pattern: Nationwide distribution: USA including states of: CA, FL, GA, MA, MN, MO, NJ, NY, OH, and WI.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Firm has become aware of an unintended behavior when using syngo.plaza and issued an Update Instruction. The Update Instruction SY050/12/S provides a software update and addresses the following issues: - Patient Rename messages for the same patient are being continually processed for several days. This fills up the 'pcvdbsrv' log and potentially affects performance of the system. - Data could