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Recall Observatory FDA recall evidence

Device product

Syngo.plaza. A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning.

Z-1354-2015

February 18, 2015

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 70596
Status
Terminated
Classification
Class II
Quantity
4
Official record key
device-enforcement:Z-1354-2015

Official wording

Reason: Possibly incomplete archived studies during pre-fetch. In a server farm setup, when pre-fetch/retrieve operation is performed for partially archived studies, the series that have not yet been archived, will remain unarchived.

Code information: Model Numbers of device: 10592457, 10863172, serial numbers: 100177 100033 100181 100029

Distribution pattern: US Distribution: MA, WI, FL

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Possibly incomplete archived studies during pre-fetch. In a server farm setup, when pre-fetch/retrieve operation is performed for partially archived studies, the series that have not yet been archived, will remain unarchived.