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Recall Observatory FDA recall evidence

Device product

syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Up Model Number 11061620. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.

Z-0995-2022

March 07, 2022

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 89915
Status
Terminated
Classification
Class II
Quantity
1 (US)
Official record key
device-enforcement:Z-0995-2022

Official wording

Reason: 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.

Code information: Partial UDI: 04056869051314, Serial Number 112261

Distribution pattern: Worldwide 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.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software version makes an automatic change in laser configuration settings for "markerless workflow" which may