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Recall Observatory FDA recall evidence

Device product

Syngo.plaza, picture archiving and communications system.

Z-1116-2017

January 11, 2017

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 76278
Status
Terminated
Classification
Class II
Quantity
62 systems
Official record key
device-enforcement:Z-1116-2017

Official wording

Reason: Software update for improvements and to resolve several issues

Code information: Model Number: 10863171, 10863172, 10863173 Serial Numbers: 100262 100198 100258 100259 100135 100538 100133 100031 100105 100106 100109 100110 100111 100112 100113 100114 100115 100116 100117 100119 100120 100416 100461 100245 100447 100364 100298 100299 100386 100139 100027 100440 100441 100559 100025 100033 100196 100189 100190 100191 100192 100195 100186 100232 100450 100449 100256 100199 100188 100194 100198 100029 100253 100203 100204 100132 100139 100434 100476 100495 100491 100206

Distribution pattern: Distributed throughout the United States.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Software update for improvements and to resolve several issues