BEUDAMED
    FDA Enforcement Class II Terminated

    Fona Srl IntraOs 70 intra-oral x-ray system IntraOS 70 is an extra oral source X-ray system for dental radiographic examination and diagnosis of diseases of the teeth.

    Recall: Z-1179-2013 · Reported May 29, 2013

    Enforcement

    Recall Number
    Z-1179-2013
    Event ID
    65018
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Chicago X-Ray Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 29, 2013
    Initiation Date
    July 3, 2012
    Classification Date
    May 21, 2013
    Termination Date
    September 5, 2017
    Address
    65 E Palatine Rd Ste 121, N/A, Prospect Heights, IL, 60070-1845, United States

    Description

    Fona Srl IntraOs 70 intra-oral x-ray system IntraOS 70 is an extra oral source X-ray system for dental radiographic examination and diagnosis of diseases of the teeth.

    Reason

    The IntraOs 70 system was found to have missing or incomplete system labels as required by 21 CFR 1010.2 & 1010.3. Also, the user's manual was found to have missing or improperly labeled information as required by 21 CFR 1020.30(h).

    Code Info

    Model IntraOs 70

    Distribution

    Worldwide Distribution- USA (nationwide) and Latin America.

    Quantity

    1960 units