The Recall Desk
HighFDA (Devices)·Z-1112-2019·Announced 2019-04-17

Siemens syngo.CT Cardiac Function Software Recalled for TAVI Measurement Risk

Siemens is recalling syngo.CT Cardiac Function software due to a potential risk of wrong measurement in the annulus plane during TAVI planning.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (wrong measurement) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling syngo.via syngo.CT Cardiac Function software, Model Number 10496180. The recall involves 112 total units distributed nationwide in the United States, including states such as 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. The affected software versions are VA20A, VA30A, or VB10A.

The recall is due to a software issue found in the TAVI algorithm that creates a potential risk of a wrong measurement in the annulus plane during a TAVI planning procedure. The software packages are designed to support physicians in determining functional parameters of the left and right ventricles and evaluating cardiac CT angiography volume sets.

Healthcare facilities and users should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the software issue. No specific consumer action is detailed in the source text beyond the recall notification.

The recalled product

Product
syngo.via syngo.CT Cardiac Function, 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 p
Manufacturer
Siemens Medical Solutions USA, Inc
Category
Medical Device — Software
Hazard
Affected units
112

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Software versions VA20A
  • VA30A or VB10A

Distribution

Distributed nationwide across the United States.

The notice also names 33 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Siemens Medical Solutions USA, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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