medical Class II Updated 2021-03-24

Siemens Medical Solutions USA, Inc recalls Software versions syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a

Recalled 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)


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Software versions syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a
View official government recall

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