Simpleware ScanIP 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 software, used to transfer imaging information from medical scanners and simulate surgical treatments, has been recalled due to a bug that can display anatomical orientation tags and labels incorrectly. This software issue could lead operators to misunderstand image data and make errors when resampling or realigning images. The affected versions are Simpleware ScanIP 7.0 (created before December 2, 2014), version 2016.09, version M-2017.06, and version N-2018.03. The recall affects four software installations distributed nationwide in California and Florida, as well as in France, the United Kingdom, Germany, and Australia.
The recall notice does not specify a remedy or corrective action for affected consumers.
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: 4 softwares Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.