Devices

Device Recall microTargeting Drive System

  • Model / Serial
    Serial Numbers: 14511,16997, 15104  Medtronic: 15140,15108, 15084, 15081, 21380, 21375, 15153, 15107, 15118, 15098, 15092, 15071, 21372, 21389, 21386 Manufactured after January 21, 2010 and prior to March 22, 2010.
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    microTargeting Drive System with Mounted Accessories || Catalog numbers : 66-ZD-MD-01, MT-DS-01, FC1006 (Medtronic) || 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

Manufacturer

FHC, Inc.
  • Manufacturer Address
    FHC, Inc., 1201 Main Street, Bowdoinham ME 04008
  • Manufacturer Parent Company (2017)
    Fhc Inc.
  • Source
    USFDA