medical Class II Updated 2021-08-18

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

Recalled Product

Simpleware ScanIP 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 7.0: Created before UDI-DI system (released December 2nd, 2014), Simpleware ScanIP 2016.09: 00863520000307, Simpleware ScanIP M-2017.06: 00863520000314, Simpleware ScanIP N-2018.03: 00863520000321
View official government recall

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