BEUDAMED
    FDA Recall Terminated

    IMRIS ORT 200, Removable Operating Room Table, Part Numbers: (a) 113821-000, (b) 113821-600, (c) 114148-000, (d) 114148-600 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and position a patient. The tables are indicated for imagining from head to sacrum with MR/CT imaging modalities. The ORT100 table is intended for use during diagnostic examination or surgical procedures to support and position the patient.

    Recall: Z-0647-2019 · Initiated November 6, 2018

    Recall

    Recall Number
    Z-0647-2019
    Event Number
    81574
    Firm
    Deerfield Imaging, Inc.
    FEI Number
    3010326005
    Product Code
    FQO
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    November 6, 2018
    Terminated
    July 25, 2021
    Address
    5101 Shady Oak Rd S, Minnetonka, MN, 55343-4100

    Description

    IMRIS ORT 200, Removable Operating Room Table, Part Numbers: (a) 113821-000, (b) 113821-600, (c) 114148-000, (d) 114148-600 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and position a patient. The tables are indicated for imagining from head to sacrum with MR/CT imaging modalities. The ORT100 table is intended for use during diagnostic examination or surgical procedures to support and position the patient.

    Reason

    Table may drift in the roll position while in use

    Action

    The firm initiated the recall by letter on 11/06/2018. The letter explained the issue, requested the consignee follow the recommended daily test in all positions until the roll cylinders are exchanged.

    Distribution

    Worldwide distribution - US Nationwide and countries of China, Qatar, Canada, Australia, Japan, France, Germany, Sweden, Italy.

    Quantity

    14 units