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Siemens Medical Solutions USA, Inc Recall 89915

Description: syngo.via RT Image Suite upgraded to VB60 running on syngo.via Model Number 10496180. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.

Siemens Medical Solutions USA, Inc Recall 89915 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0994-2022
Event ID89915
Event Descriptionsyngo.via RT Image Suite upgraded to VB60 running on syngo.via Model Number 10496180. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.
Product TypeDevices
DistributionWorldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, IL, IN, KY, MD, MO, ND, NH, NY, OH, OR, PA, SD, TX, VA and the countries of Argentina, Austria, Bahrain, Belgium, Brazil, Czechia, Denmark, France, Germany, Hungary, India, Italy, Japan, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Switzerland, United Kingdom.
Quantity1 (US)
Recall ReasonUpgraded 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.
Device Classification20220504
Device Code InfoSerial Number 133527
Center Classification Date20220422
Recall Initiation Date20220307
Recalling FirmSiemens Medical Solutions USA, Inc
Initial Notification E-Mail
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