The Recall Desk

FDA (Devices) recall action 82517

Siemens Medical Solutions USA, Inc recalled 2 products on 2019-04-17

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2019-04-17
Critical
0
Units
224

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··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.

    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
    Category
    Distribution
    33 states
  • HighFDA (Devices)··2019-04-17

    Siemens Medical Solutions Recalls syngo.via Cardiac Planning Software

    Siemens Medical Solutions is recalling syngo.via syngo.CT Cardiac Planning software due to a potential risk of incorrect measurements during TAVI planning procedures.

    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 p
    Category
    Distribution
    33 states