Device product
syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Sim Model Number 11061660. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.
Z-0996-2022
Product summary
- Event
- Event 89915
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15 (US)
- Official record key
device-enforcement:Z-0996-2022
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: 04056869249230, Serial Numbers 128123, 128106, 128109, 128144, 128124, 128112, 128132, 128135, 128114, 128125, 128113, 128142, 128107, 128136, 128133
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
software version makes an automatic change in laser configuration settings for "markerless workflow" which may