| Date Initiated by Firm | July 08, 2005 |
| Date Posted | September 07, 2012 |
| Recall Status1 |
Terminated 3 on January 13, 2017 |
| Recall Number | Z-2334-2012 |
| Recall Event ID |
61869 |
| Product Classification |
Booth, sun tan - Product Code LEJ
|
| Product | SUN|DASH RADIUS 252 tanning system; 52 lamps, Ultraviolet Radiation.
The device is intended to be used for tanning of the 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 | 800-445-0624 |
Manufacturer Reason for Recall | The firm has tracked a systematic failure in the door cord on the Sun|Dash Radius 252 product line. In some instances when the door cord is installed with little or no slack outside the upper decor piece, the cord has been known to fail causing a short in the wiring at the pivot point in the cord. |
FDA Determined Cause 2 | Equipment maintenance |
| Action | JK Global Services sent out Mandatory Inspection/Modification letters to their Distribution Service Teams dated 07/08/2005, 01/12/2006, 09/15/2010, 10/04/2010 and 03/01/2012. A letter dated September 15, 2010, was sent to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to contact a JK representative or their Distributor as soon as possible to schedule an inspection to the affected product in their possession. For any questions customers were instructed to call 1-800-445-0624 or send an e-mail to support@jkamerica.com. |
| Quantity in Commerce | 1948 units |
| Distribution | Worldwide Distribution - USA (nationwide) and Canada |
| 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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