Simpleware Product Group, SYNOPSYS NORTHERN EUROPE Recall 88207
Description: Simpleware ScanIP software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options.
Simpleware Product Group, SYNOPSYS NORTHERN EUROPE Recall 88207 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2253-2021 |
| Event ID | 88207 |
| Event Description | Simpleware ScanIP software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options. |
| Product Type | Devices |
| Distribution | US: Nationwide Distribution in the states of CA, FL and countries of : France, United Kingdom, Germany, Australia |
| Quantity | 4 softwares |
| Recall Reason | 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 |
| Device Classification | 20210818 |
| Device 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 |
| Center Classification Date | 20210812 |
| Recall Initiation Date | 20210604 |
| Recalling Firm | Simpleware Product Group, SYNOPSYS NORTHERN EUROPE |
| Initial Notification | Letter |
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