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Siemens syngo Dynamics Workplace, version 5.0, Siemens Medical Solutions, Ann Arbor, MI; 10090310. Intended for acceptan

FDA device recall Z-0544-2009 · posted 2009-01-02 · Terminated

Recall details

Recalling firm
Siemens Medical Solutions, USA, Inc
Reason for recall
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Action taken
Consignees were notified of the problem via a Customer Safety Advisory Notice dated 7/23/08, which provided guidance on how to minimize the risk of the problem occurring, and told customers that a service patch will be installed when it becomes available.
Root cause
Software design
Status
Terminated
Product code
LLZ
Quantity affected
306 of all products.
Distribution
Nationwide Distribution.
Date initiated
2008-07-23
Date posted
2009-01-02
Date terminated
2010-10-18
Location
Ann Arbor, MI

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Related 510(k) clearances

RecordFirmDate
SYNGO DYNAMICS, VERSION 5.0 (K053133)Siemens Medical Solutions USA, Inc.2005-12-05