BEUDAMED
    FDA Enforcement Class II Ongoing

    Sedecal NOVA FA DR System. for diagnostic radiography.

    Recall: Z-0488-2019 · Reported November 28, 2018

    Enforcement

    Recall Number
    Z-0488-2019
    Event ID
    81377
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Sedecal S.A.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 28, 2018
    Initiation Date
    July 18, 2018
    Classification Date
    November 20, 2018
    Address
    Pol. Industrial Rio De Janiero, Calle Pelaya 9-13, Algete, N/A, N/A, Spain

    Description

    Sedecal NOVA FA DR System. for diagnostic radiography.

    Reason

    A safety problem with installation and maintenance could lead to the breakage of the two steel cables that support the equipment to its roof anchor. Due to this, the equipment may fall and cause harm to the patient, user, or third parties.

    Code Info

    Serial Numbers 07360816 through 17291024

    Distribution

    US and Canada

    Quantity

    145 units