Simpleware ScanIP software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options.
FDA Recall Z-2253-2021 · Posted None
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Recalling FirmSimpleware Product Group, SYNOPSYS NORTHERN EUROPE
Recall StatusTerminated
Product CodeLLZ
Date Initiated2021-06-04
Date Terminated2022-09-29
Product Quantity4 softwares
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
Firm Action
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 [email protected]
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
Root Cause
Software Manufacturing/Software Deployment
Distribution Pattern
US: Nationwide Distribution in the states of CA, FL and countries of : France, United Kingdom, Germany, Australia
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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