Z-2253-2021 Class II Terminated
FDA device recall Z-2253-2021 was initiated by Simpleware Product Group, SYNOPSYS NORTHERN EUROPE on June 4, 2021 and is designated Class II. 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 misunderst… The recall status is terminated (terminated September 29, 2022). Affected quantity: 4 softwares.
Recall Details
- Product Type
- Devices
- Report Date
- August 18, 2021
- Initiation Date
- June 4, 2021
- Termination Date
- September 29, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 softwares
Product Description
Simpleware ScanIP 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 Pattern
US: Nationwide Distribution in the states of CA, FL and countries of : France, United Kingdom, Germany, Australia
Code Information
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