BEUDAMED
    FDA Enforcement Class II 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 · Reported July 31, 2019

    Enforcement

    Recall Number
    Z-2076-2019
    Event ID
    83310
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    LABORIE MEDICAL TECHNOLOGIES, CORP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 31, 2019
    Initiation Date
    July 17, 2019
    Classification Date
    July 25, 2019
    Termination Date
    July 10, 2023
    Address
    400 Avenue D Ste 10, N/A, Williston, VT, 05495-7828, United States

    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

    Code Info

    Serial Numbers: PE18-7SBL1452, PE18-7SBL 1414

    Distribution

    US distribution in AZ, and PA.

    Quantity

    2 US