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U.S. Department of Health and Human Services

Class 2 Device Recall DCI

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  Class 2 Device Recall DCI see related information
Date Initiated by Firm May 01, 2007
Date Posted July 12, 2007
Recall Status1 Terminated 3 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 2		 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.
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