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Simpleware Product Group, SYNOPSYS NORTHERN EUROPE recalls Simpleware ScanIP medical software. For transfer of imaging information from a medical scanner to an output file, and f
Recalled August 18, 2021 · FDA recall Z-2254-2021 · Simpleware Product Group, SYNOPSYS NORTHERN EUROPE
Hazard
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 · FDA Class II
Units
6 software's
Sold at
US: Nationwide Distribution in the states of CA, FL and countries of : France, United Kingdom, Germany, Australia
Description
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
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.
Manufacturer(s)
Simpleware Product Group, SYNOPSYS NORTHERN EUROPE
Made in
United Kingdom
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →