Z-2834-2011

LuxStar Dental Light have the following Agency model or Catalog Model numbers as ML1000, OL1000, CL1000...

Name: Z-2834-2011 LuxStar Dental Light have the following Agency model or Catalog Model numbers as ML1000, OL1000, CL1000...
Creator: Dental Equipment LLC
Published: 2011-05-27
License: https://open.fda.gov/license/

DCI International, LLC / initiated 2011-05-27 / Terminated / root cause: design

FDA source

Dental Equipment LLC began a recall of LuxStar Dental Light have the following Agency model or Catalog Model numbers as ML1000, OL1000, CL1000, WL1000, CB1000, TL1000, and UL1000. The product is... on 2011-05-27. The reason FDA records is "Lens heat shield (birdcage) of the Luxstar Dental Light could fall and injure a patient". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2834-2011
Status: Terminated
Initiated: 2011-05-27
Posted: 2011-07-15
Terminated: 2012-10-24
Recalling firm: DCI International, LLC
Product: 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.
Product code: EAZ Light, Operating, Dental
Reason for recall: Lens heat shield (birdcage) of the Luxstar Dental Light could fall and injure a patient.
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 13,226 units distributed worldwide
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 codes and lots: 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 code EAZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)