Atlas FDA

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

FDA device recall Z-0465-2013 · posted 2012-12-03 · Terminated

Recall details

Recalling firm
Siemens Medical Solutions USA, Inc
Reason for recall
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
Action taken
The firm, Siemens, sent "Update Instruction SY050/12/S" on June 20, 2012 to its consignees/customers. The Update Instructions described the product, problem and actions to be taken. It also provides a software update. If you have any questions call 610-219-4834 or email: anastasia.mason@siemens.com.
Root cause
Software design
Status
Terminated
Product code
LLZ
Quantity affected
15
Distribution
Nationwide distribution: USA including states of: CA, FL, GA, MA, MN, MO, NJ, NY, OH, and WI.
Date initiated
2012-06-20
Date posted
2012-12-03
Date terminated
2014-01-14
Location
Malvern, PA

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Related 510(k) clearances

RecordFirmDate
SYNGO.PLAZA (K093612)Siemens AG Medical Solutions2010-03-04