Events

Recall of Device Recall 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
    31718
  • Event Risk Class
    Class 2
  • Event Number
    Z-0895-05
  • Event Initiated Date
    2005-03-14
  • Event Date Posted
    2005-06-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-07-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38388
  • 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
    Potential for non-sterile pin to contaminate sterile field.
  • Action
    FHC notified customers by letter dated 3/14/05 and 3/25/05. The firm has issued a temporary set of instructions which include covering the non-sterile engagement pin with sterile tape and an amended Instruction For Use page to all customers. A redesigned pulley cover which will be sent to all customer when it becomes available in April 2005.

Device

Device Recall FHC
  • Model / Serial
    All codes
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Natiowide
  • Product Description
    FHC 66-ZD-MD microTargeting Drive System: System for Stereotactic Positioning || Used with the Power Assist (66-DA-ME) or Display Assembly (66-DA-EN)
  • Manufacturer
    FHC, Inc.

Manufacturer

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