Simpleware ScanIP medical software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options.
Check against the official notice below — it lists the full affected range.
Simpleware ScanIP medical software versions O-2018.12, P-2019.09, Q-2020.03, Q-2020.06, R-2020.09, and R-2021.03 have been recalled due to a software bug that causes anatomical orientation tags and labels to display incorrectly. This defect could lead operators to misunderstand the orientation information and make errors when resampling or realigning medical imaging data. The affected software was distributed in California and Florida in the United States, as well as in France, the United Kingdom, Germany, and Australia.
The recall notice does not specify a remedy or instructions for affected consumers regarding this issue.
Written by software from the official notice below. Not reviewed by a lawyer.
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
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 Quantity: 6 software's Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.