FDA recall Z-2254-2021

Simpleware Product Group, SYNOPSYS NORTHERN EUROPE · Class II · device

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.

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

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

Key facts

Status
Terminated
Initiation date
2021-06-04
Report date
2021-08-18
Termination date
2022-09-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Exeter, N/A, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2254-2021