BEUDAMED
    FDA Enforcement Class II 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 · Reported November 28, 2018

    Enforcement

    Recall Number
    Z-0388-2019
    Event ID
    81454
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    GE Healthcare Biosciences
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    November 28, 2018
    Initiation Date
    September 10, 2018
    Classification Date
    November 20, 2018
    Termination Date
    May 12, 2020
    Address
    14 Walkup Dr, N/A, Westborough, MA, 01581-1019, United States

    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.

    Code Info

    System Serial number OM20072 - OM40122

    Distribution

    Worldwide - US Nationwide Distribution

    Quantity

    39