Simpleware Product Group, SYNOPSYS NORTHERN EUROPE recalls Simpleware ScanIP software. For transfer of imaging information from a medical scanner to an output file, and for simul…

Recall date

June 4, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2253-2021

FDA classification

Class II

Brand / firm

Simpleware Product Group, SYNOPSYS NORTHERN EUROPE

Sold / distributed

US: Nationwide Distribution in the states of CA, FL and countries of : France, United Kingdom, Germany, Australia

Why it was 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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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