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.
FDA Recall Z-0997-2022 · Posted None
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Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2022-03-07
Date Terminated2023-12-19
Product Quantity14 (US)
Reason for Recall
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.
Firm Action
4/4/22 update: Urgent Medical Device Correction letter has not been issued. The proposed letter informs customers of software issue and workaround to resolve issue. It also requires electronic signature to acknowledge receipt of the notification. If you have additional questions contact the service organization at 1-800-888-7436.
Root Cause
Software change control
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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