BEUDAMED
    FDA Enforcement Class II Ongoing

    Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728333 - Spectral CT:

    Recall: Z-1986-2021 · Reported July 7, 2021

    Enforcement

    Recall Number
    Z-1986-2021
    Event ID
    87974
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Philips North America Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 7, 2021
    Initiation Date
    May 1, 2021
    Classification Date
    June 30, 2021
    Address
    222 Jacobs St, N/A, Cambridge, MA, 02141-2289, United States

    Description

    Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728333 - Spectral CT:

    Reason

    Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining attached to the cables resulting in patient, operator, bystander, or service person to serious injury.

    Code Info

    Model/ Serial Number/UDI: N/A 10016 (01)00884838101111(21)10016 10018 (01)00884838101111(21)10018

    Distribution

    Worldwide distribution - US Nationwide and the countries of Canada, Mexico, AE, AR, AT, AU, BD, BE, BR, CH, CL, CN, CO, CU, CY, CZ, DE, DK, DZ, EE, EG, ES, FI, FR, GB, GE, GI, GL, GR, HK, HU, ID, IE, IL, IN, IQ, IR, IT, JO, JP, KE, KG, KH, KR, LA, LB, LK, LT, LY, MM, MN, MU, MV, MY, NI, NL, NO, NZ, OM, PA, PF, PH, PK, PL, PS, PT, QA, RE, RU, RW, SA, SE, SG , SI, SK, TH, TN, TR, UZ, VN, XK, YE, ZA, ZW.

    Quantity

    1,301 Monitor Bracket Assemblies total