Simpleware Product Group, SYNOPSYS NORTHERN EUROPE: Medical Device Recall in 2021 - (Recall #: Z-2254-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: June 4, 2021

Date Posted: August 18, 2021

Recall Number: Z-2254-2021

Event ID: 88207

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

Status: Terminated

Product Quantity: 6 software's

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated