Company:Siemens Medical Solutions USA, Inc
Date of Enforcement Report 12/12/12
Class ll:
PRODUCT
Siemens syngo.plaza Radiological Image Processing System Usage: Radiological Image Processing System. Recall Number Z-0465-2013
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 remain unprotected and not archived leading to a potential data loss. – System crashes when user tries to delete a self created spine labeling step. – For datasets with corrupt PR objects, not all images are loaded to Viewer and no Ferro message is displayed for the user. – 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. – Viewer crashes during load of next patient. Error is related to ‘Next Patient’ from RIS.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Malvern, PA on 6/20/2012. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
15
DISTRIBUTION
USA including states of: CA, FL, GA, MA, MN, MO, NJ, NY, OH, and WI.
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