BEUDAMED
    FDA Recall Terminated

    Simpleware ScanIP medical software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options.

    Recall: Z-2254-2021 · Initiated June 4, 2021

    Recall

    Recall Number
    Z-2254-2021
    Event Number
    88207
    Firm
    Simpleware Product Group, SYNOPSYS NORTHERN EUROPE Bradninch Hall Castle Street Exeter United Kingdom
    FEI Number
    3011676026
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software Manufacturing/Software Deployment
    Initiated
    June 4, 2021
    Terminated
    September 29, 2022

    Description

    Simpleware ScanIP medical software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options.

    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

    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

    Distribution

    US: Nationwide Distribution in the states of CA, FL and countries of : France, United Kingdom, Germany, Australia

    Quantity

    6 software's