Events

Retiro De Equipo (Recall) de RF MultiGen, 0406900000; Refurb RF MultiGen, 0406900000U

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 Stryker Instruments Div. of Stryker Corporation.

¿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
    75485
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0584-2017
  • Fecha de inicio del evento
    2016-10-11
  • Fecha de publicación del evento
    2016-11-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-07-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150479
  • 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
    Generator, lesion, radiofrequency - Product Code GXD
  • Causa
    Stryker instruments is voluntarily recalling the care instructions/instructions for use packaged with the radiofrequency (rf) multigen¿ generator, because the instructions for use incorrectly contained instructions supporting the sterilization of the multigen¿ cables.
  • Acción
    Stryker Instruments initiated a voluntary recall of the RF MultiGen, and Refurb RF MultiGen because the instructions for use contained incorrect instructions on sterilizing the device. Stryker distributed customer notices via certified mail on 10/11/2016. Customer's were instructed to do the following: Immediately review this recall notification. 2. Enclosed was a revised version of the IVS Care Instructions. Please distribute the revised version to the appropriate person or department. 3. Remove and discard any previously distributed IVS Care Instructions or Instructions for Use. 4. Please complete, sign, and return the enclosed Business Reply Form (BRF) acknowledging your receipt and understanding of this notification. 5. Fax the completed BRF to Stryker Instruments Regulatory Department, 866-521-2762, or scan and email a copy to kellyjo.davis@stryker.com. Customers with questions can contact: 269 323 7700 .

Device

RF MultiGen, 0406900000; Refurb RF MultiGen, 0406900000U
  • Modelo / Serial
    RF MultiGen¿, 0406-900-000, Refurb RF MultiGen¿, 0406-900-000U
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Domestic:AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY Foreign:France, Germany, Canada, UK, Lebanon, South Africa, Chile, Hong Kong, Poland, Argentina, Spain, Greece, Italy, India, Brazil, Switzerland, Netherlands, Sweden VA/DOD:
  • Descripción del producto
    RF MultiGen¿, 0406-900-000; Refurb RF MultiGen¿, 0406-900-000U
  • Manufacturer
    Stryker Instruments Div. of Stryker Corporation

Manufacturer

Stryker Instruments Div. of Stryker Corporation
  • Dirección del fabricante
    Stryker Instruments Div. of Stryker Corporation, 4100 E Milham Ave, Portage MI 49002-9704
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    USFDA