Atlas FDA

Syngo.plaza; picture archiving and communications system Product Usage: Syngo.plaza is a Picture Archiving and Communica

FDA device recall Z-2719-2015 · posted 2015-09-02 · Terminated

Recall details

Recalling firm
Siemens Medical Solutions USA, Inc
Reason for recall
Potential issue leading to data loss and patient data mix-up
Action taken
Siemens sent a Customer Information letter, dated July 6, 2015, to customers The letter identified the affected product, problem and action to be taken. The letter informed cusotmers about the Hotfix software update that was being released.
Root cause
Software design
Status
Terminated
Product code
LLZ
Quantity affected
37
Distribution
US Nationwide Distribution - in the states of CA, OR, FL, MO, NY, WA, MD, MA, NY, WI, KS, MN and PA.
Date initiated
2015-07-06
Date posted
2015-09-02
Date terminated
2017-01-06
Location
Malvern, PA

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Related 510(k) clearances

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