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U.S. Department of Health and Human Services

Class 2 Device Recall SUN DASH RADIUS 252

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  Class 2 Device Recall SUN DASH RADIUS 252 see related information
Date Initiated by Firm July 25, 2014
Date Posted September 12, 2014
Recall Status1 Terminated 3 on January 13, 2017
Recall Number Z-2635-2014
Recall Event ID 69038
510(K)Number K932483  
Product Classification Booth, sun tan - Product Code LEJ
Product SUN DASH RADIUS 252 PN 8000809705.

The device is intended to be used for the tanning of human skin.
Code Information PN 8000809705; Serial numbers 248-1298
Recalling Firm/
Manufacturer		 JK Products & Services, Inc
1 Walter Kratz Dr
Jonesboro AR 72401-0609
For Additional Information Contact
870-268-2852
Manufacturer Reason
for Recall		 The integrity of the wires inside main electrical chord become compromised from excessive flexing (during the door open/close process).
FDA Determined
Cause 2		 Device Design
Action The owners of the affected device will be notified via certified letter. After the recalling firm confirms ownership, a technician will be dispatched to install a door clamp and door stop, and inspect the condition of the main electrical chord.
Quantity in Commerce 1948 units
Distribution Nationwide Distribution.
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.
510(K) Database 510(K)s with Product Code = LEJ and Original Applicant = SUN IND., INC.
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