Sollux Systeme commercial tanning beds; Soleil Systems, Inc. The following models are affected by this recall: a) Sollux Systeme 32 - 32 x 100 w tanning bulbs, no facial tanner bulbs b) Sollux Systeme 32.3 - 32 x 100 w tanning bulbs, plus 3 x 400 w facial tanner bulbs c) Sollux Systeme 36 - 18 x 100 w reflective tanning bulbs, 18 x 100 w tanning bulbs, no facial tanner bulbs d) Sollux Systeme 36.3 - 18 x 100 w reflective tanning bulbs, 18 x 100 w tanning bulbs, plus 3 x 400 w facial tanner bulbs e) Sollux System 40 - 20 x 160 w reflective tanning bulbs, 20 x 100 w reflective tanning bulbs, no facial tanner bulbs f) Sollux System 40.3 - 20 x 160 w reflective tanning bulbs, 20 x 100 w reflective tanning bulbs, 3 x 400 w facial tanner bulbs
FDA Recall Z-1065-04 · Posted None
Recalling FirmSoleil Systems, Inc.
Recall StatusTerminated
Product CodeU--19
Date Initiated2004-08-02
Date Terminated2006-03-28
Product Quantity70 beds
Reason for Recall
The sunlamp products failed to incorporate a timer system and a control for termination of radiation emission in accordance with the Federal Sunlamp Product Performance Standard.
Firm Action
Soleil Systems sent recall notification letters dated 6/28/04 to their dealers on 8/2/04, informing them of the noncompliances of failing to incorporate a permanently mounted timer and on/off switch in the sunbeds. Soleil will bring each sunbed into compliance and requested the dealers to review their sales records for any Sollux beds received between 4/28/04 and 11/01/03, and supply Soleil with a list of names and addresses of end users who received those units. Soleil sent out end user notifications dated 8/20/04 beginning on 8/23/04 and initiated the retrofit of the sunbeds on 10/25/04.
Root Cause
Other
Distribution Pattern
The sunbeds were distributed through dealers in Missouri, Texas, Virginia, Kentucky and Illinois
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.