BEUDAMED
    FDA Enforcement Class II Ongoing

    MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700)

    Recall: Z-2397-2023 · Reported August 16, 2023

    Enforcement

    Recall Number
    Z-2397-2023
    Event ID
    92720
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Philips North America
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 16, 2023
    Initiation Date
    June 12, 2023
    Classification Date
    August 10, 2023
    Address
    222 Jacobs St, N/A, Cambridge, MA, 02141-2296, United States

    Description

    MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700)

    Reason

    The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after a smoke detection by power cycling the system.

    Code Info

    Product Number: 782120: UDI-DI: 00884838104112; Serial Numbers: 65041 65031 65030 65025 65023 65019 65013 65009 65008 65007 65006 65005 65004 65003 65002 65000 65020 65012 65034 65001; Product Number 782130: UDI-DI: 00884838104402; Serial Numbers: 45301 45298 45007 45297 45557

    Distribution

    US Nationwide. Global Distribution.

    Quantity

    640 total