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U.S. Department of Health and Human Services

Class 2 Device Recall Sollux Systeme

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  Class 2 Device Recall Sollux Systeme see related information
Date Initiated by Firm August 02, 2004
Create Date June 25, 2015
Recall Status1 Terminated 3 on March 28, 2006
Recall Number Z-1065-04
Recall Event ID 29737
Product Classification unknown device name - Product Code U--19
Product 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
Code Information Each sunbed has two serial numbers, one on the canopy and another on the bench. The serial numbers listed below list the canopy/bench.serial numbers followed by the manufacturing date.  a) Sollux Systeme 32 - 22 units, serial numbers 320002/320007 May 03; 320008/320014 May 03; 320010/320010 May 03; 320012/320012 May 03; 320015/321207 May 03; 320016/320016 May 03; 320017/320017 May 03; 320018/320018 May 03; 320019/320019 May 03; 320020/321202 May 03; 320021/321211 May 03; 320095/321264 Oct 03; 320096/321325 Oct 03; 320104/321284 Jun 03; 320106/321320 Jun 03; 320109/320109 May 03; 320111/321319 Aug 03; 320112/321314 Aug 03; 320123/321317 Sep 03; 320214/320214 May 03; 321211/321211 May 03; 321324/320113 Aug 03;   b) Sollux Systeme 32.3 - 7 units, serial numbers 320007/321104 May 03; 320008/321109 May 03; 320009/321112 May 03; 320011/321316 Aug 03; 320093/321269 Oct 03; 320126/321268 Oct 03; 320127/321323 Oct 03;   c) Sollux Systeme 36 - 8 units, serial numbers  360004/360016 Sep 03; 360009/360015 May 03; 360012/361003 May 03; 360013/360021 Jun 03; 361001/360013 Aug 03; 361003/360017 Aug 03; 361041/361004 Oct 03; 361042/361001 Aug 03;   d) Sollux Systeme 36.3 - 8 units, serial numbers 360011/360019 May 03; 360012/360015 May 03; 360013/360020 Jun 03; 360015/360010 May 03; 360016/360011 May 03; 360018/360014 My 03; 360020/360023 May 03; 360021/360027 May 03;  e) Sollux System 40 - 1 unit, serial number  400002/400008 May 03;   f) Sollux System 40.3 - 24 units, serial numbers 400002/400010 May 03; 400003/400021 Jul 03; 400004/400005 May 03; 400005/400020 Jun 03; 400006/400014 Jun 03; 400007/400004 Jun 03; 400008/400019 Aug 03; 400009/400094 Aug 03; 400010/400005 Jul 03; 400011/400023 Aug 03; 400012/400016 Apr 03; 400013/400017 Oct 03; 400116/400001 Sep 03; 400019/400020 Oct 03; 400021/400013 Aug 03; 400090/400015 Aug 03; 400095/400010 Aug 03; 400096/400021 Sep 03; 400097/400013 Oct 03; 400099/400018 Sep 03; 400102/400015 Sep 03; 400113/400012 Jul 03; 400114/400002 JUL 03; 400115/400009 Jul 03;
Recalling Firm/
Manufacturer		 Soleil Systems, Inc.
360 Scott St
Elk Grove Village IL 60007-1215
For Additional Information Contact Mr. James J. Falcione
800-385-9750
Manufacturer 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.
FDA Determined
Cause 2		 Other
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.
Quantity in Commerce 70 beds
Distribution The sunbeds were distributed through dealers in Missouri, Texas, Virginia, Kentucky and Illinois
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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