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