Events

Retiro De Equipo (Recall) de Sollux Systeme

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Soleil Systems, Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    29737
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1065-04
  • Fecha de inicio del evento
    2004-08-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-03-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34451
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    unknown device name - Product Code U--19
  • Causa
    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.
  • Acción
    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.

Device

Sollux Systeme
  • Modelo / Serial
    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;
  • Distribución
    The sunbeds were distributed through dealers in Missouri, Texas, Virginia, Kentucky and Illinois
  • Descripción del producto
    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
  • Manufacturer
    Soleil Systems, Inc.

Manufacturer

Soleil Systems, Inc.
  • Dirección del fabricante
    Soleil Systems, Inc., 360 Scott St, Elk Grove Village IL 60007-1215
  • Source
    USFDA