LuxStar Dental Light have the following Agency model or Catalog Model numbers as ML1000, OL1000, CL1000, WL1000, CB1000,

FDA device recall Z-2834-2011 · posted 2011-07-15 · Terminated

Recall details

Recalling firm

Dental Equipment LLC

Reason for recall

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

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

EAZ

Quantity affected

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,

Date initiated

2011-05-27

Date posted

2011-07-15

Date terminated

2012-10-24

Location

Newberg, OR