BEUDAMED
    FDA Recall Terminated

    Ingenia MR-OR; 781437, 781438 The MR-OR option is intended for allowing transfer of a neurosurgical patient from OR suite to MR suite and back with tools and instructions for proper positioning and MR imaging of those patients. MR-OR option also facilitates execution of simple neurosurgical procedures in the near proximity of the MR scanner without a need to move the patient back to the OR suite

    Recall: Z-0825-2017 · Initiated December 1, 2016

    Recall

    Recall Number
    Z-0825-2017
    Event Number
    75844
    Firm
    Philips Electronics North America Corporation
    FEI Number
    1218950
    Product Code
    LNH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 1, 2016
    Posted
    December 19, 2016
    Terminated
    August 31, 2017
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032

    Description

    Ingenia MR-OR; 781437, 781438 The MR-OR option is intended for allowing transfer of a neurosurgical patient from OR suite to MR suite and back with tools and instructions for proper positioning and MR imaging of those patients. MR-OR option also facilitates execution of simple neurosurgical procedures in the near proximity of the MR scanner without a need to move the patient back to the OR suite

    Reason

    Possibility that a patient or user may be exposed to a very small level of touch current.

    Action

    Philips sent an Urgent Field Safety Notice Medical Device Correction letter dated November 2016 to all affected customers. The letter explains the issue and actions planned by Philips. There is no need for action to be taken by customer or user. Customers with questions should contact their local Philips representative Technical Support Line 1-800-722-9377.

    Distribution

    Worldwide Distribution -US including CA, NY and Internationally to United Kingdom, Australia, Norway, and Thailand

    Quantity

    9