BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-2253-2021 · Reported August 18, 2021

    Enforcement

    Recall Number
    Z-2253-2021
    Event ID
    88207
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Simpleware Product Group, SYNOPSYS NORTHERN EUROPE
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 18, 2021
    Initiation Date
    June 4, 2021
    Classification Date
    August 12, 2021
    Termination Date
    September 29, 2022
    Address
    Bradninch Hall, Castle Street, Exeter, N/A, N/A, United Kingdom

    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

    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

    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

    Distribution

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

    Quantity

    4 softwares