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FDA device recall Z-1688-2017 · posted 2017-03-27 · Terminated

Recall details

Recalling firm
Siemens Medical Solutions USA, Inc
Reason for recall
Software changes now available to address several issues
Action taken
Siemens sent a notice dated March 7, 2017, to affected customers on to inform them that software updates via the latest syngo.via software was now available to that would address several issues that were reported. Customers were asked to forward the notice to the new owner. For questions regarding this recall call 610-448-6481.
Root cause
Software design
Status
Terminated
Product code
LLZ
Quantity affected
104 systems
Distribution
Nationwide Distribution.
Date initiated
2017-03-06
Date posted
2017-03-27
Date terminated
2017-06-12
Location
Malvern, PA

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Related 510(k) clearances

RecordFirmDate
SYNGO.X (K092519)Siemens AG Medical Solutions2009-08-27