BEUDAMED
    FDA Enforcement Class II Ongoing

    Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 16 System Number: 882470 Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologists to produce real-time CT images to facilitate image-guided surgery.

    Recall: Z-0280-2022 · Reported December 1, 2021

    Enforcement

    Recall Number
    Z-0280-2022
    Event ID
    89039
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Philips North America Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 1, 2021
    Initiation Date
    May 1, 2021
    Classification Date
    November 23, 2021
    Address
    222 Jacobs St, Cambridge, MA, 02141-2289, United States

    Description

    Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 16 System Number: 882470 Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologists to produce real-time CT images to facilitate image-guided surgery.

    Reason

    Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Monitor Bracket Assembly detaching from the Suspension Arm, and resulting in injury to patient, operator, bystander, or service person located in the path of a falling part

    Code Info

    Serial Number: 7084 7145 7584

    Distribution

    US (nationwide) distribution to states of: CA, ME, TX and OUS (Foreign) to countries of: Australia, Germany, Netherlands and Saudi Arabia.

    Quantity

    3 units