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Recall Observatory FDA recall evidence

Device product

Syngo.plaza software VB10A model numbers: 10863171, 10863172, 10863173 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-1699-2018

February 20, 2018

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 79740
Status
Terminated
Classification
Class II
Quantity
92
Official record key
device-enforcement:Z-1699-2018

Official wording

Reason: Software upgrade to correct format of study dates and issues with Legacy Presentation States (annotations) in order to prevent potential patient misdiagnosis.

Code information: All Serial Numbers

Distribution pattern: USA (nationwide)

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    Software upgrade to correct format of study dates and issues with Legacy Presentation States (annotations) in order to prevent