—#171745

Product

syngo.via syngo.CT Cardiac Planning, Model Number 10496180 Product Usage: Syngo.CT Cardiac Planning and syngo CT. Cardiac Function are image analysis software packages for evaluating cardiac CT angiography (CTA) volume sets. The software packages are designed to support the physician in determining the functional parameters of the left and right ventricles, confirming the presence or absence of physicianidentified myocardial enhancement defects and evaluation documentation and follow-up of any such finding.

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K170221
Affected lot / code info: Software versions VB20A or VB30A

Why it was recalled

There is a potential risk of a wrong measurement in the annulus plane during a TAVI planning procedure. This risk is due to a software issue found in the TAVI algorithm.

Root cause (FDA determination)

Software design

Action the firm took

Urgent Customer Safety Advisory Notice letters dated 3/20/19 were sent to customers. The letter identified the affected product, problem and actions to be taken. For questions call 1-800-888-7436.

Recalling firm

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

Distribution

Distribution pattern: US Nationwide Distribution in the states of: AK, AL, AR, AZ, CA, CT, FL, GA, IA, IL, KS, KY, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, and WI.

Timeline

Recall initiated: 2019-03-21
Terminated: 2022-01-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #171745. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.