syngo.via syngo.CT Cardiac Function recall: Software Issue
syngo.via syngo.CT Cardiac Function, Model Number 10496180 Product Usage: Syngo.CT Cardiac Planning and syngo CT. Cardiac Function are image analysis…
Why was syngo.via syngo.CT Cardiac Function 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Software versions VA20A, VA30A or VB10A
- Product
- syngo.via syngo.CT Cardiac Function, Model Number 10496180 Product Usage: Syngo.CT Cardiac Planning and syngo CT. Cardiac Function are image analysis…
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 112 total
- Distribution
- 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.
- Recall date
- April 17, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)