medical Class II Updated 2019-09-11

Siemens Medical Solutions USA, Inc recalls syngo.CT software version VA48A_SP5.5 in the following SOMAT

Recalled 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

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: syngo.CT software version VA48A_SP5.5
View official government recall

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