Devices

Device Recall STar Drive System

  • Modèle / numéro de série
    Serial Numbers:  20640, 21292, 21182, 21276, 21267, 21183, 20605 Manufactured after January 21, 2010 and prior to March 22, 2010.
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA in the states of AZ, CA, FL, ID, NC, MA, MI, MN, NV, RI, UT, VA, and WA, and countries of Columbia and South Africa.
  • Description du dispositif
    STar Drive System, || Catalog numbers: ST-DS-MA, ST-DS-ME, 70-ZD-ME || Product is the FHC DBS Depth Stop Adapter, a component of the microTargeting Drive and the STar Drive. The Drives are intended to be used with commercially available stereotactic systems for neurosurgical procedures which require the accurate positioning of microelectrodes, stimulating electrodes, or other instruments in the brain or nervous system.
  • Manufacturer
    FHC, Inc.
  • 1 Event

Fabricant

FHC, Inc.
  • Adresse du fabricant
    FHC, Inc., 1201 Main Street, Bowdoinham ME 04008
  • Société-mère du fabricant (2017)
    Fhc Inc.
  • Source
    USFDA