Device Recall HiResolution Bionic Ear System

  • Model / 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.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    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.
  • Product Description
    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
  • 1 Event

Manufacturer

  • Manufacturer Address
    Advanced Bionics Corporation, 12740 San Fernando Rd, Bldgs. 1 & 3, Sylmar CA 91342
  • Source
    USFDA

One device with a similar name

Learn more about the data here

  • Model / 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.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    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.
  • Product Description
    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