BEUDAMED
    FDA Recall Open, Classified

    Sedecal NOVA FA DR System. for diagnostic radiography.

    Recall: Z-0488-2019 · Initiated July 18, 2018

    Recall

    Recall Number
    Z-0488-2019
    Event Number
    81377
    Firm
    Sedecal S.A. Pol. Industrial Rio De Janiero Calle Pelaya 9-13 Algete Spain
    FEI Number
    3002495042
    Product Code
    MQB
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    July 18, 2018

    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.

    Action

    Initial communication from SEDECAL to all our distributors was performed on 07/18/2018 by email. The letter explained the problem and requested the consignee cease use of the unit if they observe an abnormal displacement in the vertical axis or any suspicious noise during the vertical movement.

    Distribution

    US and Canada

    Quantity

    145 units