Events

Retiro De Equipo (Recall) de Device Recall HiResolution Bionic Ear System

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 Advanced Bionics 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
    34873
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0758-06
  • Fecha de inicio del evento
    2006-03-08
  • Fecha de publicación del evento
    2006-04-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-03-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44868
  • 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
    Cochlear Implant - Product Code MCM
  • Causa
    Certain hires 90k cochlear implants could fail as a result of elevated moisture levels. the unimplanted hires 90k implants listed are being removed from the market. patients are to be followed for signs of device failure: intermittent function, complete loss of sound, sudden discomfort, pain, noise, or popping.
  • Acción
    The recall was initiated on 03/08/06. In North America, the clinician notification letters were distributed by fax. For other regions, an Advanced Bionics representative and/or distributor are providing notification to the affected clinicians. As part of the clinician notification process, each center was provided with a list of their affected devices. Customers were given a list of HiRes 90K implants with feedthrus from Supplier B that were shipped to their clinic and are not yet registered with Advanced Bionics. Customers were asked to return the implants listed in the attachment to Advanced Bionics according to the instructions. Customers were told not to implant any of the devices on the list. Customers were told that implants manufactured wth feedthrus from Supplier A will be delivered quickly to minimize disruptions to their schedule. Customers will be contacted through Advanced Bionics Customer Service within 48 hours to arrange retrieval of implants manufactured with feedthrus from Supplier B and replacement with implants manufactured with feedthrus from Supplier A.

Device

Device Recall HiResolution Bionic Ear System
  • Modelo / Serial
    Model CI-1400-01. Serial numbers: 310383, 306002, 224839, 310129, 308039, 310558, 225444, 225541, 301020, 309066, 310003, 310135, 310284, 310141, 310142, 310490, 310466, 310475, 309002, 303070, 306090, 310712, 310023, 222652, 223588, 300220, 301490, 302089, 303086, 307009, 310495, 225722, 304072, 304086, 304093, 310007, 310116, 310286, 310332, 302219, 310138, 310136, 310444, 310557, 310718, 310336, 307093, 222772, 310439, 301394, 300216, 304094, 306045, 310131, 310170, 310391, 310354, 310461, 309058, 310115, 310165, 310392, 310485, 305062, 310211, 308057, 310161, 310440, 301381, 225289, 301094, 225603, 306078, 310421, 220798, 222078, 225301, 307059, 309004, 310010, 310125, 310373, 310418, 310643, 310130, 306075, 302023, 301969, 301979, 310012, 223481, 310424, 222826, 310698, 303085, 308022, 310347, 310031, 310034, 301809, 301818, 310148, 310231, 310566, 310788, 307063, 304045, 301835, 310013, 310508, 302109, 302135, 306011, 220223, 303059, 310433, 225560, 225725, 301347, 310313, 310376, 310459, 310639, 310792, 302036, 310284, 309034, 309009, 309013, 310127, 310128, 302114, 305010, 306015, 308031, 222653, 224598, 301517, 222982, 225438, 310242, 310295, 310330, 310393, 310510, 310672, 310638, 310493, 301885, 225384, 225396, 225400, 225463, 225565, 310486, 302285.
  • Clasificación del producto
    Ear, Nose, and Throat Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Nationwide to: AR, AL, FL, TX, NY, NE, NC, CO, GA, OH, IL, PA, IN, MN, NC, CA, HI, MA, AZ, VA, OR, SD, MI, MO, IA, UT, TN. Worldwide to: Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Columbia, Costa Rica, Cuba, Denmark, Ecuador, Egypt, France, Germany, Hong Kong, India, Israel, Italy, Japan, Lebanon, Mexico, Morocco, Netherlands, Norway, Poland, Portugal, Puerto Rico, Serbia, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, Venezuela.
  • Descripción del producto
    The unimplanted HiRes90K Implantable Cochlear Stimulators (ICS) manufactured with feedthrus from a specific supplier are being removed from the market. Model number CI-1400-01
  • Manufacturer
    Advanced Bionics Corporation

Manufacturer

Advanced Bionics Corporation
  • Dirección del fabricante
    Advanced Bionics Corporation, 12740 San Fernando Rd, Bldgs. 1 & 3, Sylmar CA 91342
  • Source
    USFDA