Home / Recalls / Simpleware Product Group, SYNOPSYS NORTHERN EUROPE / Z-2254-2021

Z-2254-2021 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: 6 software's

Product Description

Simpleware ScanIP medical 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 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