medical Class II Updated 2021-08-18

Simpleware Product Group, SYNOPSYS NORTHERN EUROPE recalls Simpleware ScanIP medical software. For transfer of imaging

Recalled 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.

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: Affected version/UDI: Simpleware ScanIP Medical; Simpleware ScanIP O-2018.12: 00863520000338, Simpleware ScanIP Medical; Simpleware ScanIP P-2019.09: 00863520000345, Simpleware ScanIP Medical; Simpleware ScanIP Q-2020.03: 00863520000369, Simpleware ScanIP Medical; Simpleware ScanIP Q-2020.06: 00863520000352, Simpleware ScanIP Medical; Simpleware ScanIP R-2020.09: 00863520000376, Simpleware ScanIP Medical; Simpleware ScanIP R-2021.03: 00863520000383

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