Class 2 Device Recall DCI

• Date Initiated by Firm: May 01, 2007
• Date Posted: July 12, 2007
• Recall Status: Terminated on July 12, 2007
• Recall Number: Z-1077-2007
• Recall Event ID: 38169
• Product Classification: dental light - Product Code EAZ
• Product: DCI Equipment Track Mount Light Assembly, 110v
• Code Information: All products of this type. Product does not contain serial numbers or any other identifying codes.
• Recalling Firm/ Manufacturer: Dental Equipment LLC; 705 S Springbrook Rd Bldg B200; Newberg OR 97132-7057
• For Additional Information Contact: Wendy Urtel; 714-516-7400
• Manufacturer Reason for Recall: Potential for light shield to melt due to light assemblies not properly rated to handle the VAC.
• FDA Determined Cause: Other
• Action: On 5/1/07 the dental office contacted the manufacturer via telephone regarding the incident. On 5/2/07 the firm's service representative visited the dental office and replaced the lights.
• Quantity in Commerce: 4 dual track lights
• Distribution: The lights were distributed to one distributor in NY who in turn distributed the lights to one dental office.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.