Device Recall HiRes90K Platinum Series Headpiece

  • Modèle / numéro de série
    Model #AB-7300-001; Serial Numbers: 167419, 167420, 169309, 169310, 169311, 170983, 170984, 170985, 172709, 172710, 174272, 174274, 174275, 174298, 175139, 175988, 175989, 175990, 175991, 177627, 177628, 177629, 177630, 177631, 177671, 177672, 177673, 178494, 179252, 181303, 181304, 183489, 184405 and 184694
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide
  • Description du dispositif
    HR90K Platinum Series Headpiece Model Number AB-7300-001 ADVANCED BIONICS LLC 12740 San Fernando Rd. Sylmar, CA 91342 USA. The HiRes90K headpiece is used in conjunction with speech processors manufactured by Advanced Bionics. || The Harmony HiResolution Bionic Ear System and Clarion Multi-Strategy Cochlear Implant are cochlear implant systems designed to provide useful hearing to individuals with severe-to-profound sensorineural hearing loss.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Advanced Bionics LLC, 12740 San Fernando Rd, Sylmar CA 91342-3728
  • Société-mère du fabricant (2017)
  • Source
    USFDA