BEUDAMED
    FDA Enforcement Class II Terminated

    Helios HL3T and HLT Track Mounted Dental Lights Product Usage: The product is intended for use by dental professionals to illuminate the oral cavity while performing examinations and dental procedures.

    Recall: Z-1268-2016 · Reported April 6, 2016

    Enforcement

    Recall Number
    Z-1268-2016
    Event ID
    73460
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Pelton & Crane / Marus / DCI Equipment / KaVo
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 6, 2016
    Initiation Date
    March 8, 2016
    Classification Date
    March 28, 2016
    Termination Date
    June 6, 2016
    Address
    11727 Fruehauf Dr, N/A, Charlotte, NC, 28273-6507, United States

    Description

    Helios HL3T and HLT Track Mounted Dental Lights Product Usage: The product is intended for use by dental professionals to illuminate the oral cavity while performing examinations and dental procedures.

    Reason

    The firm received two customer complaints local Pelton & Crane distributors that the Helios 3000 track mounted dental lights were missing the two 8/32x3/16 set screws during the initial installation of the dental light.

    Code Info

    Model/Serial No. - HLT-5535, 5543, 5536, 5537, 5538, 5556, 5540, 5541, 5545, 5546, 5515, 5500, 5503, 5520, 5521, 5547, 5548, 5549, 5550, 5551, 5552, 5510, 5558, 5522, 5523, 5524, 5525, 5526, 5527, 5528, 5529, 5530, 5531, 5532, 5501, 5502, 5504, 5505, 5534, 5508, 5509, 5533, 5516, 5517, 5518, 5519, 5544, 5553, 5554, 5555, 5542, 5557, 5506, 5507, 5511, 5498, 5539, 5499, 5512, 5513, 5514; Model/Serial No. HL3T-11110, 11102, 11103, 11104, 11105, 11106, 11099, 11164, 11165, 11166, 11167, 11193, 11170, 11171, 11118, 11119, 11120, 11145, 11146, 11147, 11148, 11149, 11121, 11123, 11150, 11113, 11114, 11115, 11116, 11117, 11168, 11169, 11158, 11187, 11133, 11144, 11136, 11137, 11138, 11139, 11140, 11141, 11142, 11143, 11177, 11111, 11112, 11135, 11190, 11191, 11192, 11100, 11182, 11183, 11185, 11186, 11134, 11122, 11124, 11125. 11126, 11127, 11128, 11129, 11130, 11131, 11132, 11155, 11156, 11157, 11159, 11160, 11161, 11107, 11108, 11176, 11172, 11173, 11174, 11175, 11109. 11151, 11152, 11153, 11154, 11101, 11181, 11184, 11188, 11189, 11178, 11179, 11180, 11162, 11163

    Distribution

    US Nationwide Distribution in the states of AZ, AR, CA, CO, CT, FL, IA, ID, IL, IN, MA, MI, MN, NJ, NY, NC, OH, OR, PA, TN, TX, UT, VA, WI and Canada

    Quantity

    156 units