medical Class II Updated 2022-05-04

Siemens Medical Solutions USA, Inc recalls syngo.via RT Image Suite upgraded to VB60 running on SOMATO

Recalled Product

syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Open Pro Model Number 11061670. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.

Hazard / Issue

Upgraded software version makes an automatic change in laser configuration settings for "markerless workflow" which may lead to the wrong laser offset coordinates being displayed in the Patient Marking step.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: Partial UDI: 04056869249247, Serial Numbers 130088, 130081, 130075, 130090, 130087, 130074, 130069, 130091, 130092, 130086, 130079, 130089, 130077, 130071

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