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…
    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…
    Category
    Distribution
    33 states