—#192915

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.

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K200524
Affected lot / code info: Partial UDI: 04056869249230, Serial Numbers 128123, 128106, 128109, 128144, 128124, 128112, 128132, 128135, 128114, 128125, 128113, 128142, 128107, 128136, 128133

Why it was recalled

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.

Root cause (FDA determination)

Software change control

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

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.

Timeline

Recall initiated: 2022-03-07
Terminated: 2023-12-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #192915. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.