Events

Recall of Device Recall FHC microTargeting Guideline 4000

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
    54278
  • Event Risk Class
    Class 2
  • Event Number
    Z-1143-2010
  • Event Initiated Date
    2009-12-28
  • Event Date Posted
    2010-03-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-03-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88119
  • 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
    Depth Electrode - Product Code GZL
  • Reason
    The raster tab for the gl4k version 1.4 software may assign incorrect depths for waveform recordings and if used to identify the implantation target for the dbs lead, the implant may be placed in the wrong location.
  • Action
    FHC notified customers by telephone and by an Urgent: Medical Device Correction email, dated December 2009, beginning December 28th. Customers have been instructed to keep the instruction with the GL4K until FHC can provide a revision to the software; and, to use only "distance from zero" or "distance traveled" modes (not "distance from target" mode) during procedures using the raster tab. Customers are to notify their FHC representative to confirm receipt of the notification. A software patch has been verified and validated and will be installed on all affected units. The new version of the corrected software is Guideline 4000 version 1.41. Questions should be directed to Jason Moyer, product manager or Keri Seitz, recall coordinator at 207-666-8190.

Device

Device Recall FHC microTargeting Guideline 4000
  • Model / Serial
    Software ver 1.4, Serial Numbers: 19454, 14423, 17349, 19215, 15573, 19424, 17583, 17589, 17588, and 17581. This version of software was released in August 2009
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, including states of GA, MA, NC, NJ, OH, RI, TN, TX, and WV and Bucharest, Romania.
  • Product Description
    FHC microTargeting Guideline 4000 ver 1.4 (GL4K) Software, || Catalog # MT-GL4K. || Intended to assist in functional neurological procedures.
  • Manufacturer
    FHC, Inc.

Manufacturer

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