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
  • 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
  • 1 Event

Fabricante

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

Dispositivo con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Model CI-1400-02H. Serial numbers: 350550, 350974, 350386, 350613, 350654, 350687, 350714, 350754, 350859, 350964, 350998, 351006, 351031, 351035, 351063, 351129, 351132, 351139, 350568, 350121, 350486, 350514, 350581, 350655, 350896, 350955, 350958, 350967, 350452, 350816, 350949, 350959, 350963, 351021, 351140, 350489, 350492, 350505, 350555, 350789, 350910, 250914, 350957, 351036, 350565, 351020, 350251, 350283, 350482, 350509, 350519, 350524, 350525, 350527, 350531, 350532, 350583, 350676, 350689, 351046, 350535, 350220, 350224, 350239, 350246, 350250, 350254, 350256, 350260, 350294, 351069.
  • Clasificación del producto
  • 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-1400-02H.
  • Manufacturer