BEUDAMED
    FDA Recall Terminated

    U3-3 Solar Blue, Laptop integrated power supply used with the Solar Blue Urodynamics for assessing lower urinary tract dysfunctions

    Recall: Z-2076-2019 · Initiated July 17, 2019

    Recall

    Recall Number
    Z-2076-2019
    Event Number
    83310
    Firm
    LABORIE MEDICAL TECHNOLOGIES, CORP
    FEI Number
    3017448360
    Product Code
    FEN
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 17, 2019
    Terminated
    July 10, 2023
    Address
    400 Avenue D, Ste 10, Williston, VT, 05495-7828

    Description

    U3-3 Solar Blue, Laptop integrated power supply used with the Solar Blue Urodynamics for assessing lower urinary tract dysfunctions

    Reason

    Power supply unit (PS-SBL) not correctly labeled, and insulation material used at the low voltage DC end does not meet all applicable flammability rating requirements. may lead to a potential fire hazard

    Action

    Laborie issued letter via FedX on July 17, 2019 advising of the problem, health risk, and action to take: Quarantine the product and unplug the power supply from the wall socket until a replacement is provided. A new power supply unit(s) will be provided along with instructions on how to replace the power supplie in the field. Contact Laborie/MMS customer care with any questions, concerns or problems: Laborie MMS Customer Care Address: 400 Avenue D, Suite 10, Williston, VT 05495 Phone Number: 800.522.6743 Email: [email protected]

    Distribution

    US distribution in AZ, and PA.

    Quantity

    2 US