Events

Recall of Device Recall LuxStar Dental Light

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Dental Equipment LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    59099
  • Event Risk Class
    Class 2
  • Event Number
    Z-2834-2011
  • Event Initiated Date
    2011-05-27
  • Event Date Posted
    2011-07-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-10-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=101128
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Light, operating, dental - Product Code EAZ
  • 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.

Device

Device Recall LuxStar Dental Light
  • Model / Serial
    LuxStar Dental Light does not have Serial Number. They are identified by Catalog Model numbers such as ML1000, OL1000, CL1000, WL1000, CB1000, TL1000, and UL1000.
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • 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.
  • Product 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.
  • Manufacturer
    Dental Equipment LLC

Manufacturer

Dental Equipment LLC
  • Manufacturer Address
    Dental Equipment LLC, 705 S Springbrook Rd Bldg B200, Newberg OR 97132-7057
  • Source
    USFDA