Events

Recall of FHC Microtargeting Drive System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by FHC, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    50086
  • Event Risk Class
    Class 2
  • Event Number
    Z-0486-2009
  • Event Initiated Date
    2008-10-08
  • Event Date Posted
    2008-12-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74697
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Stereotaxic Instrument - Product Code HAW
  • Reason
    Measuring fixture is incorrectly graduated.
  • Action
    FHC provided letter notification to FHC Field Representatives on 10/08/08 to hand deliver to customers. FHC Field Representatives will remove incorrectly marked product and provide replacement product. Direct questions to an FHC representative or FHC Quality and Regulatory Affairs at 207-666-5651, ext. 2210.

Device

FHC Microtargeting Drive System
  • Model / Serial
    Not coded.
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including states of CO, FL, NC and NM.
  • Product Description
    FHC microTargeting Platform DBS Measuring Fixture, || a component of the micro-targeting Drive System (Catalog Number 66-FA-SF). || The device is a stereotactic instrument used for the placement of recording and stimulating electrodes in the brain.
  • Manufacturer
    FHC, Inc.

Manufacturer

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