BEUDAMED
    FDA Enforcement Class II Terminated

    Ingenia 1.5T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Number: 781341

    Recall: Z-2342-2021 · Reported September 1, 2021

    Enforcement

    Recall Number
    Z-2342-2021
    Event ID
    88461
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips North America Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    September 1, 2021
    Initiation Date
    July 30, 2021
    Classification Date
    August 25, 2021
    Termination Date
    July 25, 2023
    Address
    222 Jacobs St, N/A, Cambridge, MA, 02141-2289, United States

    Description

    Ingenia 1.5T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Number: 781341

    Reason

    Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury

    Code Info

    S/N and UDI: 84344 (01)00884838055322(21)84344; 87019 (01)00884838055322(21)87019; 87231 (01)00884838055322(21)87231. OUS: 87171 (01)00884838055322 84943 (01)00884838055322 87142 (01)00884838055322 87249 (01)00884838055322 87252 (01)00884838055322 87195 (01)00884838055322 87129 (01)00884838055322 87136 (01)00884838055322 87175 (01)00884838055322 87196 (01)00884838055322 87197 (01)00884838055322 87235 (01)00884838055322 87187 (01)00884838055322 87212 (01)00884838055322 84572 (01)00884838055322 87116 (01)00884838055322 87152 (01)00884838055322 87161 (01)00884838055322 87237 (01)00884838055322 87244 (01)00884838055322 87090 (01)00884838055322 87093 (01)00884838055322 87259 (01)00884838055322 87209 (01)00884838055322

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, MD, MD, NH, NY, OH, TN, TX, VA and the countries of Canada, Mexico, Australia, Austria, Chile, China, Czech Republic, Denmark, France, Germany, India, Indonesia, Italy, Japan, Korea, Republic of Lebanon, Netherlands, Romania, Russian Federation, Saudi Arabia, Spain, Turkey, Ukraine, United Kingdom.

    Quantity

    3 units US; 24 units OUS