BEUDAMED
    FDA Enforcement Class II Ongoing

    First Source iQ Flex M. Portable cart and platform that supports an X-ray system and laptop computer.

    Recall: Z-2247-2024 · Reported July 10, 2024

    Enforcement

    Recall Number
    Z-2247-2024
    Event ID
    94744
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    First Source Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 10, 2024
    Initiation Date
    May 9, 2024
    Classification Date
    July 1, 2024
    Address
    3495 Winton Pl Bldg E, Ste 1, Rochester, NY, 14623-2824, United States

    Description

    First Source iQ Flex M. Portable cart and platform that supports an X-ray system and laptop computer.

    Reason

    Potential for the bolt that secures the positioning arm to the gas spring to come loose and fall onto patient.

    Code Info

    Model No. Pending; UDI-DI: G221500MC0740; Serial No. 4001, 4002, 4003, 4004, 4005, 4006, 4007, 4008, 4009, 4010, 4011, 4012, 4013, 4014, 4015, 4016, 4017, 4018, 4019, 4020, 4021, 4022, 4023, 4024, 4025, 4026, 4027, 4028, 4029, 4030, 4031, 4032, 4033, 4034, 4035, 4036, 4037, 4038, 4039, 4040, 4041, 4042, 4043, 4044, 4045, 4046, 4047, 4048, 4049, 4050, 4051, 4052, 4053, 4054, 4055, 4056, 4057, 4058, 4059, 4060.

    Distribution

    Worldwide - US Nationwide distribution in the states of AR, CA, FL, GA, IL, IN, LA, MA, MD, MI, MO, MS, NC, NY, OK, PA, TN, TX, & VA. The countries of Korea & Serbia.

    Quantity

    137 units