Devices

Device Recall HiResolution Bionic Ear System

  • Modèle / numéro de série
    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.
  • Classification du dispositif
    Ear, Nose, and Throat Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    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.
  • Description du dispositif
    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
  • 1 Event

Fabricant

Advanced Bionics Corporation
  • Adresse du fabricant
    Advanced Bionics Corporation, 12740 San Fernando Rd, Bldgs. 1 & 3, Sylmar CA 91342
  • Source
    USFDA

Un dispositif médical avec un nom similaire

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Device Recall HiResolution Bionic Ear System
  • Modèle / numéro de série
    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.
  • Classification du dispositif
    Ear, Nose, and Throat Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    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.
  • Description du dispositif
    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
    Advanced Bionics Corporation