Device product

syngo.CT software version VA48A_SP5.5 in the following SOMATOM computed tomography models: SOMATOM Definition Edge-Model #10590000; SOMATOM Definition AS Model #8098027; SOMATOM Definition Flash Model #10430603

Z-2440-2019

July 25, 2019

Class II

Product summary

Firm: Siemens Medical Solutions USA, Inc
Event: Event 83519
Status: Terminated
Classification: Class II
Quantity: 2867 units worldwide (OUS); 1464 units US
Official record key: device-enforcement:Z-2440-2019

Official wording

Reason: SOMATOM Definition Edge, SOMATOM Definition AS, SOMATOM Definition Flash with software syngo.CT with Software version VA48A_SP5 may result in scanning workflow interruptions and unexpected user notifications. and may result in a delay in diagnosis and/or patient rescans

Code information: syngo.CT software version VA48A_SP5.5

Distribution pattern: Nationwide Foreign:

Derived failure modes

Device software or design
reason.device_software_design · v1.0.0

software syngo.CT with Software version VA48A_SP5 may result in scanning workflow interruptions