BEUDAMED
    FDA Enforcement Class II Ongoing

    Intera 1.5T Omni/Stellar; Product Number: 781104;

    Recall: Z-1934-2025 · Reported June 18, 2025

    Enforcement

    Recall Number
    Z-1934-2025
    Event ID
    96999
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Philips North America
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 18, 2025
    Initiation Date
    May 29, 2025
    Classification Date
    June 9, 2025
    Address
    222 Jacobs St, Cambridge, MA, 02141-2296, United States

    Description

    Intera 1.5T Omni/Stellar; Product Number: 781104;

    Reason

    identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage.

    Code Info

    Product Number: 781104; UDI-DI: no UDI; Serial Numbers: 10403, 18969;

    Distribution

    Worldwide - US Nationwide distribution in the states of AZ, CA, DE, MA, MI, MY, NE, NY, SD and the countries of Australia, Brazil, Ecuador, Germany, Iran, Italy, Japan, Lebanon, Libya, Mexico, Poland, Portugal, Spain.

    Quantity

    2 units (OUS only)