Events

Recall of FHC

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
    33946
  • Event Risk Class
    Class 2
  • Event Number
    Z-0179-06
  • Event Initiated Date
    2005-10-31
  • Event Date Posted
    2005-11-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-06-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42773
  • 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
    Neurological Stereotaxic Instrument - Product Code HAW
  • Reason
    Power assist microtargeting system may advance beyond intended target.
  • Action
    FHC Inc. and Medtronic notified customers by letter and instructs the customer to return their Motor Option for upgrade to include the following components: 1) Handheld Remote Control, 2) Motor Controller Unit with Display, 3) Motor, and 4) Medical Power Adapter. (See pictures at the end of this communication). Until the Motor Option has been updated, instructions to customers are: Prior to each clinical use: ¿ Ensure the microTargeting Drive system is calibrated before each clinical use per the User Guide. ¿ Check the microTargeting Drive system functionality over a range of at least 10mm movement. ¿ Should any performance indicating either a stall or unintended movement be observed, immediately unplug the 12V Medical Power Adapter, remove the MicroTargeting Drive Motor Option from the system, and continue using the microTargeting Drive in the manual mode. During clinical use: ¿ Should any performance indicating either a stall or unintended movement be observed, immediately unplug the 12V Medical Power Adapter, remove the MicroTargeting Drive Motor Option from the system, and continue using the microTargeting Drive in the manual mode. Every 100 uses or annually: ¿ Have your microTargeting Drive system checked by the manufacturer per the User Guide. ¿ Have your equipment support department check or tighten the MicroTargeting Drive Motor Option Remote Control Knob set screws, tighten as needed, and then re-calibrate.

Device

FHC
  • Model / Serial
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Foreign: South Africa, Taiwan, Hong Kong, China, France
  • Product Description
    FHC microTargeting Power Assist System used with the micro Targeting Drive System, models: 66-DA-ME; 66EL-MC; 66EL-MS;66EL-MS-02; 66-EL-MS-03; 66-EL-RM; MT-DS-AM; MT-DS-MD.
  • Manufacturer
    FHC, Inc.

Manufacturer

FHC, Inc.
  • Manufacturer Address
    FHC, Inc., 9 Main St, Bowdoinham ME 04008-4418
  • Source
    USFDA