Simpleware Product Group, SYNOPSYS NORTHERN EUROPE Bradninch Hall Castle Street Exeter United Kingdom Simpleware ScanIP software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Simpleware ScanIP software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options.
Brand
Simpleware Product Group, SYNOPSYS NORTHERN EUROPE Bradninch Hall Castle Street Exeter United Kingdom
Lot Codes / Batch Numbers
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
Products Sold
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
Simpleware Product Group, SYNOPSYS NORTHERN EUROPE Bradninch Hall Castle Street Exeter United Kingdom is recalling Simpleware ScanIP software. For transfer of imaging information from a medical scanner to an output due to A issue (bug) has been identified with the interface and image software which could result in anatomical orientation tags/labels being displayed inco. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
Synopsys sent a "Urgent Field Safety Notice" on June 18, 2021 via E-Mail. In addition to informing consignees about the recall, the firm request consignees take the following actions: 1. The user should stop using Simpleware ScanIP Medical R-2021.03 and earlier versions and immediately upgrade to the latest version (S-2021.06a/S-2021.06) of the software on SolvNetPlus. 2. The user should also uninstall and/or delete previous installers. 3. If this is not immediately possible, the user should always remove all DICOM tags before: " Using the Register datasets tool through the GUI or scripting. " Or applying any image rotation transforms (e.g. align or flip) through the GUI or scripting. This action can be completed by using the DICOM tags tool in the General section of the Home tab. 4. Complete the customer reply form by July 2, 2021 and submit to via Email simpleware-qms@synopsys.com Customer Helpline +44(0)1392 428752 Postal Address: Simpleware Product Group, Synopsys Northern Europe Ltd., Bradninch Hall, Castle Street, Exeter, Devon, EX4 3PL, UK Web Portal: https://www.synopsys.com/simpleware.html Fax: N/A
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026