BEUDAMED
    FDA Recall Terminated

    LuxStar Dental Light have the following Agency model or Catalog Model numbers as ML1000, OL1000, CL1000, WL1000, CB1000, TL1000, and UL1000. The product is labeled in part: " Marus Dental***Mfg By: Dental Equipment LLC.***705 S. Springbrook Rd Building C Newberg, Oregon, 97132 USA***Dental Light***MN ML1000***". Product Usage: The intended use of the dental light is used for illuminating the oral cavity during the performance of dental procedures.

    Recall: Z-2834-2011 · Initiated May 27, 2011

    Recall

    Recall Number
    Z-2834-2011
    Event Number
    59099
    Firm
    Dental Equipment LLC
    FEI Number
    1000523896
    Product Code
    EAZ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 27, 2011
    Posted
    July 15, 2011
    Terminated
    October 24, 2012
    Address
    705 S Springbrook Rd, Bldg B200, Newberg, OR, 97132-7057

    Description

    LuxStar Dental Light have the following Agency model or Catalog Model numbers as ML1000, OL1000, CL1000, WL1000, CB1000, TL1000, and UL1000. The product is labeled in part: " Marus Dental***Mfg By: Dental Equipment LLC.***705 S. Springbrook Rd Building C Newberg, Oregon, 97132 USA***Dental Light***MN ML1000***". Product Usage: The intended use of the dental light is used for illuminating the oral cavity during the performance of dental procedures.

    Reason

    Lens heat shield (birdcage) of the Luxstar Dental Light could fall and injure a patient.

    Action

    Dental Equipment, LLC sent an "URGENT MEDICAL DEVICE RECALL" notification letter via USPS 1st class to US consignees and via Federal Express or Fax to foreign consignees on June 24, 2011. The letter informed customers about the product, problem and tether upgrade corrective action. A Field Correction Acknowledgement Form and the Field Correction Completion Form was attached for customers to complete and return via the fax number 503-537-3617. The letter states that customers are to review their records in order to identify where the affected devices are located and which are still in service. Customers can call the Customer Service at 800-304-5332 and order the self-install Upgrade Kits with the Part Number 30792 at no charge. Customers are instructed to complete the Rework Correction Form once all of the lights have been updated and fax or mail to Marcus, attention Bonnie Dundas, at (503) 537-3617.

    Distribution

    Worldwide Distribution -- USA (nationwide) including states of: CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, and Puerto Rico and the countries of: Australia, Belgium, Canada, France, Germany, Ireland, Italy, Mexico, Norway, Poland, Russia, United Kingdom, Vietnam, and Trinidad.

    Quantity

    13,226 units distributed worldwide