BEUDAMED
    FDA Recall Open, Classified

    cone-beam CT system

    Recall: Z-1101-2019 · Initiated December 31, 2018

    Recall

    Recall Number
    Z-1101-2019
    Event Number
    82045
    Firm
    KaVo Dental Technologies LLC
    FEI Number
    1017522
    Product Code
    OAS
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    December 31, 2018
    Address
    11727 Fruehauf Dr, Charlotte, NC, 28273-6507

    Description

    cone-beam CT system

    Reason

    ORTHOPANTOMOGRAPH OP 3D device has a defect in the device firmware versions 2.1.0 and 2.1.1

    Action

    Palodex Group Oy sent a Notification letter to affected customers on or about December 31, 2018. The letter identified the affected product, problem and actions to be taken. The firm corrective action is to update the firmware of ORTHOPANTOMOGRAPH OP 3D of the defective units. Acknowledgement to the field correction letter is requested within 30 days from receiving the letter.

    Distribution

    US distribution in NC

    Quantity

    230