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Siemens Medical Solutions USA, Inc Recall 87454

Description: 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)

Siemens Medical Solutions USA, Inc Recall 87454 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1253-2021
Event ID87454
Event DescriptionSoftware 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)
Product TypeDevices
DistributionUS Nationwide distribution.
Quantity190 units US
Recall ReasonSOMATOM 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
Device Classification20210324
Device Code InfoSoftware versions syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a
Center Classification Date20210315
Recall Initiation Date20210303
Recalling FirmSiemens Medical Solutions USA, Inc
Initial Notification E-Mail
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