Product Wiki · Recalls · U.S. FDA — Device Enforcement

Syngo Dynamics v9.5 system — recall Z-1613-2014

U.S. FDA — Device Enforcement · United States · 2014-04-03 · Class II

As described by U.S. FDA — Device Enforcement: Syngo Dynamics v9.5 system. A Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation.

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1613-2014
Date of alert
2014-04-03
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Siemens Medical Solutions USA, Inc
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
US Nationwide Distribution in the states of AR, CA, CT, GA, IA, IL, KS, MA, MI, MN, NJ, NM, NY, OH, OR, PA, TX, TN, TX, WA, WI, and WV.
Reported risk: Systems with the affected serial number are experiencing a software error which may lead to incorrect patient demographics display.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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