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Recall Observatory FDA recall evidence

Device product

Syngo.plaza, Picture Archiving and Communication System

Z-2891-2016

September 06, 2016

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 75171
Status
Terminated
Classification
Class II
Quantity
47 systems
Official record key
device-enforcement:Z-2891-2016

Official wording

Reason: Software upgrade to eliminate several issues

Code information: Serial Numbers: 100262 100198 100258 100259 100538 100133 100213 100214 100031 100484 100362 100416 100461 100457 100447 100139 100027 100559 100440 100441 100025 100084 100186 100189 100190 100191 100192 100195 100196 100033 100232 100449 100450 100199 100256 100228 100425 100029 100253 100203 100204 100132 100434 100491 100495 100206

Distribution pattern: Distributed Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Software upgrade to eliminate several issues