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Recall Observatory FDA recall evidence

Device product

Syngo.plaza, Picture Archiving and Communications System (PACS) Syngo.plaza is 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. Syngo.plaza also supports storage and archiving of DICOM Structured reports. In a comprehensive imaging syngo.plaza integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific workflows. Syngo.plaza optionally uses a variety of advanced postprocessing applications

Z-1533-2017

February 20, 2017

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 76639
Status
Terminated
Classification
Class II
Quantity
13 systems
Official record key
device-enforcement:Z-1533-2017

Official wording

Reason: Software updates

Code information: Device Model Number: 10863171, 10863173 Serial Numbers: 100213 100484 100362 100457 100314 100300 100306 100307 100449 100450 100247 100221 100212

Distribution pattern: Nationwide Distribution to MO,TX, FL, MA, WI, PA, IN, and CA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Software updates