Medical Device
Manufacturing
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Z-2334-2012Class II

SUN|DASH RADIUS 252 tanning system; 52 lamps, Ultraviolet Radiation. The device is intended to be used for...

JK Products & Services, Inc / initiated 2005-07-08 / Terminated / root cause: manufacturing process

JK Products & Services, Inc began a recall of SUN|DASH RADIUS 252 tanning system; 52 lamps, Ultraviolet Radiation. The device is intended to be used for tanning of the human skin on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-2334-2012
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
JK Products & Services, Inc
Product
SUN|DASH RADIUS 252 tanning system; 52 lamps, Ultraviolet Radiation. The device is intended to be used for tanning of the human skin.
Product code
LEJ Booth, Sun Tan
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.
Root cause tag
manufacturing process
FDA root cause
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 [email protected].
Quantity in commerce
1948 units
Distribution
Worldwide Distribution - USA (nationwide) and Canada
Product codes and lots
PN 8000809705; Serial numbers 248-1298

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2334-2012
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2334-2012Class IITerminatedVoluntary: Firm initiated