BEUDAMED
    FDA Recall Terminated

    Aquarius iNtuition Client Viewer. Findings Workflow module, RECIST 1.1: Picture Archiving and Communications System; Findings Workflow Modules 4.4.11.82.6784, 4.4.11.116.7134, 4.4.11.144.7589. A fully-configured iNtuition system is capable of various image processing and visualization functions, including basic features and advanced post processing modules. The system can be configured as a server with some, all, or none of its optional features disabled. The intended use of the device is to provide solutions to various medical image-analysis and viewing problems, which come about as modalities generate more and more images. It also supports image distribution over networks, and is DICOM compliant.

    Recall: Z-1070-2015 · Initiated January 21, 2015

    Recall

    Recall Number
    Z-1070-2015
    Event Number
    70426
    Firm
    TeraRecon, Inc.
    FEI Number
    3003243710
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    January 21, 2015
    Posted
    February 9, 2015
    Terminated
    September 30, 2015
    Address
    4000 E 3rd Ave, Ste 200, Foster City, CA, 94404-4805

    Description

    Aquarius iNtuition Client Viewer. Findings Workflow module, RECIST 1.1: Picture Archiving and Communications System; Findings Workflow Modules 4.4.11.82.6784, 4.4.11.116.7134, 4.4.11.144.7589. A fully-configured iNtuition system is capable of various image processing and visualization functions, including basic features and advanced post processing modules. The system can be configured as a server with some, all, or none of its optional features disabled. The intended use of the device is to provide solutions to various medical image-analysis and viewing problems, which come about as modalities generate more and more images. It also supports image distribution over networks, and is DICOM compliant.

    Reason

    Software anomaly related to RECIST1.1 target lesion evaluation criteria in Findings Workflow Module within the Aquarius iNtuition Client Viewer.

    Action

    Medical Device Correction letters were sent to all affected users on January 21, 2015 by both e-mail and physical mail - certified mail for us customers and FEDEX for international customers.

    Distribution

    Worldwide Distribution-US (nationwide) and the countries of Canada, Switzerland, Germany, France and Italy.

    Quantity

    91