BEUDAMED
    FDA Enforcement Class II Terminated

    Ingenia 1.5T Evoluton- 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: 781315

    Recall: Z-2341-2021 · Reported September 1, 2021

    Enforcement

    Recall Number
    Z-2341-2021
    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 Evoluton- 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: 781315

    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: US: 61044 (01)00884838099715(21)61044; 61047 (01)00884838099715(21)61047. OUS: 61028 (01)00884838099715 61008 (01)00884838099715 61025 (01)00884838099715 61026 (01)00884838099715 61034 (01)00884838099715 61035 (01)00884838099715 61042 (01)00884838099715 61046 (01)00884838099715 61040 (01)00884838099715 61041 (01)00884838099715 61018 (01)00884838099715 61017 (01)00884838099715 61032 (01)00884838099715 61043 (01)00884838099715 61033 (01)00884838099715 61064 (01)00884838099715

    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

    2 units US; 16 units OUS