BEUDAMED
    FDA Enforcement Class II Ongoing

    Solea Models 2.0 and 3.0 Laser Surgical Instrument, Foot Pedal assembly SUB-00434 with foot pedal CUS-00226 Rev. K reworked

    Recall: Z-0324-2024 · Reported November 29, 2023

    Enforcement

    Recall Number
    Z-0324-2024
    Event ID
    93203
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Convergent Dental
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 29, 2023
    Initiation Date
    September 1, 2023
    Classification Date
    November 17, 2023
    Address
    140 Kendrick St Bldg C3, N/A, Needham, MA, 02494-2739, United States

    Description

    Solea Models 2.0 and 3.0 Laser Surgical Instrument, Foot Pedal assembly SUB-00434 with foot pedal CUS-00226 Rev. K reworked

    Reason

    It has been found that potential unintended laser activation can occur without foot pedal depression.

    Code Info

    Solea Model 3.0: UDI-DI: 00850634007018; Serial Numbers: 0310516, 0310517, 0310518, 0310519, 0310520, 0310521, 0310522, 0310523, 0310524, 0310525, 0310526, 0310527, 0310528, 0310529, 0310530, 0310531, 0310532, 0310533, 0310534, 0310535, 0310536, 0310537, 0310538, 0310539, 0310540, 0310541, 0310542, 0310543, 0310317, 0310321, 0310322, 0300730; Solea Model 2.0: UDI-DI: 00850634007001; Serial Numbers: 0200822, 0200807, 0200810, 0200625, CDS2-U33W-1B-DE-15, 0200819, 0200401

    Distribution

    Worldwide - US Nationwide distribution in the states of AK, AL, CA, CT, FL, KY, ME, MI, MO, MT, NC, OH, OR, PA, TN, TX, UT, VA, WA, WI and the country of Canada.

    Quantity

    39 units