Skip to content
Recall Observatory FDA recall evidence

Device product

Software versions syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a in the Computed tomography systems as follows: SOMATOM go.Now (Model 11061610)SOMATOM go.Up (Models 11061620 & 11061628) SOMATOM go.All (Model 11061630) SOMATOM go.Top (Models 11061640 & 11061648) SOMATOM go.Sim (Model 11061660) SOMATOM go.Open Pro (Model 11061670) SOMATOM X.cite (Model 11330001)

Z-1253-2021

March 03, 2021

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 87454
Status
Terminated
Classification
Class II
Quantity
190 units US
Official record key
device-enforcement:Z-1253-2021

Official wording

Reason: SOMATOM systems-issues in with software syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a, may result in sporadic problems causing scanning workflow interruptions and unexpected user notifications. Delay in diagnosis or patient rescan may occur. Sporadic software errors during interventional workflows may also result

Code information: Software versions syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a, may result in sporadic problems causing scanning workflow interruptions