Home / Recalls / Simpleware Product Group, SYNOPSYS NORTHERN EUROPE / Z-2253-2021

Z-2253-2021 Class II Terminated

Recalled by Simpleware Product Group, SYNOPSYS NORTHERN EUROPE — Exeter, N/A

Recall Details

Product Type: Devices
Report Date: August 18, 2021
Initiation Date: June 4, 2021
Termination Date: September 29, 2022
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 4 softwares

Product Description

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

Reason for Recall

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

Distribution Pattern

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

Code Information

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