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 Recall Z-1113-2019 · Posted None
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Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2019-03-21
Date Terminated2022-01-11
Product Quantity112 total
Reason for Recall
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.
Firm Action
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.
Root Cause
Software design
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.
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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