BEUDAMED
    FDA Enforcement Class III Ongoing

    Intera 1.5T, Model No. 781195

    Recall: Z-0811-2024 · Reported January 31, 2024

    Enforcement

    Recall Number
    Z-0811-2024
    Event ID
    93788
    Classification
    Class III
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Philips North America
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 31, 2024
    Initiation Date
    December 29, 2023
    Classification Date
    January 25, 2024
    Address
    222 Jacobs St, N/A, Cambridge, MA, 02141-2296, United States

    Description

    Intera 1.5T, Model No. 781195

    Reason

    An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. The caution symbol on the incorrect label has a white background instead of yellow, and the label is missing the high voltage warning symbol. This presents a potential risk of electrical shock for service personnel.

    Code Info

    Model No. 781195 UDI-DI N/A Serial Number 18887 18972

    Distribution

    Worldwide - US Nationwide distribution in the states of AR, CO, IL, MD, MS, NE, TX and the countries of Brazil, Canada, China, Germany, Greece, India, Mexico, and Saudi Arabia.

    Quantity

    7 US; 16 ROW total