BEUDAMED
    FDA Recall Terminated

    DeltaVision OMX SR Imaging System Model Number: 29115476 The DeltaVision OMX SR Imaging System is a piece of laboratory equipment for super resolution imaging offluorescently-la beling biological samples. Techniques such as 3D Structured Illumination, Total Internal Reflection Fluorescence and localization microscopy may be used to examine a variety of samples over long periods of time.

    Recall: Z-0388-2019 · Initiated September 10, 2018

    Recall

    Recall Number
    Z-0388-2019
    Event Number
    81454
    Firm
    GE Healthcare Biosciences
    FEI Number
    1281317
    Product Code
    REM
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 10, 2018
    Terminated
    May 12, 2020
    Address
    14 Walkup Dr, Westborough, MA, 01581-1019

    Description

    DeltaVision OMX SR Imaging System Model Number: 29115476 The DeltaVision OMX SR Imaging System is a piece of laboratory equipment for super resolution imaging offluorescently-la beling biological samples. Techniques such as 3D Structured Illumination, Total Internal Reflection Fluorescence and localization microscopy may be used to examine a variety of samples over long periods of time.

    Reason

    Non-conformance with the DeltaVision OMX SR, the interlocks are not wired in a redundant fashion to make the interlock system single-fault tolerant.

    Action

    The firm, GE Healthcare, sent an "Important Electronic Product Radiation Warning" letter to affected customers on September 10, 2018. The letter identified the affected product, problem and actions to be taken. GE Healthcare will, without charge, remedy the defect or bring the product into compliance. Your GE Service Representative will contact you to implement the correction. For questions contact your local GEHC service representative or call 425-657-1512 or email: [email protected].

    Distribution

    Worldwide - US Nationwide Distribution

    Quantity

    39