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Recall Observatory FDA recall evidence

Device product

Syngo Dynamics v9.5 system. 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.

Z-1613-2014

April 03, 2014

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 67960
Status
Terminated
Classification
Class II
Quantity
50
Official record key
device-enforcement:Z-1613-2014

Official wording

Reason: Systems with the affected serial number are experiencing a software error which may lead to incorrect patient demographics display.

Code information: model numbers: 10091805, 10091806, 10091807, 10091673 with serial numbers: 85170 85250 85188 85191 85198 85151 85165 85241 85130 85163 85019 85287 85298 85202 85168 85068 85206 85280 85235 85195 85194 85123 85199 85364 85282 85275 85115 85062 85067 85080 85216 85218 85177 85242 85248 85237 85284 85329 85259 85279 85230 85192 85277 85278 85178 85220 85157 85114 85268 85134

Distribution pattern: US Nationwide Distribution in the states of AR, CA, CT, GA, IA, IL, KS, MA, MI, MN, NJ, NM, NY, OH, OR, PA, TX, TN, TX, WA, WI, and WV.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software error which may lead to incorrect