BEUDAMED
    FDA Enforcement Class II 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 · Reported December 28, 2016

    Enforcement

    Recall Number
    Z-0825-2017
    Event ID
    75844
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Electronics North America Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 28, 2016
    Initiation Date
    December 1, 2016
    Classification Date
    December 19, 2016
    Termination Date
    August 31, 2017
    Address
    3000 Minuteman Rd, N/A, Andover, MA, 01810-1032, United States

    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.

    Code Info

    781437: 15001, 15002, 15003 781438: 30001, 30002, 30003, 30004, 30005, 30006

    Distribution

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

    Quantity

    9