Events

Retiro De Equipo (Recall) de Device Recall Hydrospa Capsules

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 Sybaritic, 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
    52036
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1604-2009
  • Fecha de inicio del evento
    2007-06-22
  • Fecha de publicación del evento
    2009-07-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-07-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81948
  • 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
    Cabinet, moist steam - Product Code IMB
  • Causa
    A correction or removal, conducted to reduce a risk to health posed by a device, was not reported in writing to fda. sybaritic, inc. conducted a recall on dermalife 2g equipment (spajet, spa oceana, spa feng shui) because of ir fan failure which resulted in the overheating and failure of the ir emitter and surrounding assembly.
  • Acción
    Sybaritic, Inc. issued a "Safety Alert" dated April 15, 2008 informing "All Owners/Users of DermaLife 2G Equipment" of the affected device. The letter advised consignees on device use until the mandatory Filed Correction Kit is delivered. For further questions, contact Sybaritic, Inc. at 1-800-445-8418.

Device

Device Recall Hydrospa Capsules
  • Modelo / Serial
    Part E30008 SERIAL NUMBERS:  G4061142236, G4060942128, G4061052135, G4061042136, G4070142436, G4070452585, G4070252464, G4061242317, G406124307, G406124311, G4061142281, G4070242474, G4070242486, G4070342498, G4070352528, G4061142257, G4061152258, G4061152273, G4070152376, G4070252458, G407044578, G4070342548, G4060842048, G4060852049, G4061152294, G4061252303, G4061252310, G4070242461, G4060952067, G40701424121, G4070152381, G4070152387, G4070342521, G4070352544, G4070552656, G4070552644, G406055898, G4060942068, G4061042145, G4061042214, G4061052149, G4061142244, G4061242326, G4061142299, G4070342506, G4070442577, G4060852053, G4060942074, G4061142259, G4061152228, G4061152240, G4061155248, G4070142363, G4070152400, G4070152408, G4070152437, G4070252463, G4070252473, G4070342517, G4070352495, G4070342529, G4060852019, G4061042186, G4061052212, G4061142224, G4061152220, G4070242448, G4070252442, G4070252484, G4070252487, G4070342491, G4070352505, G4070352509 and G4070352516; and  Part E30008-01 SERIAL NUMBERS:  G406052055, G4061252322, G4060852052, G4070142352, G4061052190, G4061042206, G4061242342, G4061042156, G4061052173, G4061052201, G4061252318, G4060852056 and G4060842058.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- US including states of CA, IA, MN, NE, NJ, NY, TX and WA and countries of Macedonia, Hungary, Greece, South Africa, Italy, Hong Kong, United Arab Emirates, Greece, Croatia, Australia, Kuwait, Turkey, Mexico, Belgium, England, Barbados, France, Japan, Lebanon, Moldova, Poland, Portugal, Romania, Russia, Spain and Thailand.
  • Descripción del producto
    DERMALIFE Spa-Oceana 2G System. Part #E30008-01 - Spa-Oceana 2G; Assay. This is the Spa Oceana product along with a kit of products such as cleaner, aroma therapy concentrate, etc. || Part #E30008 - Spa-Oceana 2G;220V,50/60HZ-15A. This is the Spa Oceana product along with a kit of products such as cleaner, aroma therapy concentrate, etc. that is slightly different than the kit of products included in Part #E30008-01 above.
  • Manufacturer
    Sybaritic, Inc

Manufacturer

Sybaritic, Inc
  • Dirección del fabricante
    Sybaritic, Inc, 9220 James Ave S, Bloomington MN 55431-2302
  • Source
    USFDA