The Recall Desk

FDA (Devices) recall action 88207

Simpleware Product Group, SYNOPSYS NORTHERN EUROPE recalled 2 products on 2021-08-18

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
2021-08-18
Critical
0
Units
10

Why these products were recalled

A issue (bug) has been identified with the interface and image software which could result in anatomical orientation tags/labels being displayed incorrectly. This could result in operator misunderstanding and errors during resampling or re-alignment of image data

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)··2021-08-18

    Medical imaging software displays anatomical orientation tags incorrectly

    Simpleware ScanIP medical imaging software contains a bug where anatomical orientation tags display incorrectly. This could lead to operator misunderstanding and errors during image resampling and realignment.

    Product
    Simpleware ScanIP software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options.
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2021-08-18

    Simpleware ScanIP Medical Software Recall: Incorrect Anatomical Orientation Display

    Simpleware ScanIP medical software may display anatomical orientation tags incorrectly, potentially causing surgical planning errors. This FDA Class II recall affects versions from 2018–2021 distributed in the US and internationally.

    Product
    Simpleware ScanIP medical software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options.
    Category
    Distribution
    2 states