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Recall Observatory FDA recall evidence

Device product

software for Syngo Dynamics a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation. Syngo Dynamics is not intended to be used for reading of mammography images.

Z-0826-2016

January 29, 2016

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 73274
Status
Terminated
Classification
Class II
Quantity
151
Official record key
device-enforcement:Z-0826-2016

Official wording

Reason: Siemens is releasing a software update that addresses an issue of mixing data from multiple patients. In rare situations, echo trend graphs may mix data from multiple patients.

Code information: For model #10091673

Distribution pattern: US Nationwide Distribution including states of: AL AR AZ CA CO CT DE FL GA IL IN KS LA MA MD MI MN MO NC ND NE NJ NM NY OH OR PA SC TN TX UT VA WA and WI.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software update that addresses an issue