Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2635-2014Class II

SUN DASH RADIUS 252 PN 8000809705. The device is intended to be used for the tanning of human skin

JK Products & Services, Inc / initiated 2014-07-25 / Terminated / root cause: design

JK Products & Services, Inc began a recall of SUN DASH RADIUS 252 PN 8000809705. The device is intended to be used for the tanning of human skin on . FDA classified it as Class II and gives the reason as "The integrity of the wires inside main electrical chord become compromised from excessive flexing (during the door open/close process)". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-2635-2014
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
JK Products & Services, Inc
Product
SUN DASH RADIUS 252 PN 8000809705. The device is intended to be used for the tanning of human skin.
Product code
LEJ Booth, Sun Tan
Reason for recall
The integrity of the wires inside main electrical chord become compromised from excessive flexing (during the door open/close process).
Root cause tag
design
FDA root cause
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.
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-2635-2014
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2635-2014Class IITerminatedVoluntary: Firm initiated