Events

Recall of Device Recall GEHC OEC Axcess Cranial Pin

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE OEC Medical Systems, 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
    62397
  • Event Risk Class
    Class 2
  • Event Number
    Z-1989-2012
  • Event Initiated Date
    2006-11-08
  • Event Date Posted
    2012-07-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110415
  • 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
    Ge healthcare is aware of a few instances where the axcess cranial screw has broken during insertion. there is a possibility that breaking of the screws could lead to a health hazard.
  • Action
    GE Healthcare sent an "URGENT REMOVAL NOTICE" dated November 8, 2006 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Contact GE Healthcare Customer Service at 1-800-874-7378 for questions regarding this recall.

Device

Device Recall GEHC OEC Axcess Cranial Pin
  • Model / Serial
    SOT-004, SOT-005, SWT-007, SWT-008, SWT-009, SWT-010, SWT-012, SWT-013, 1W9239/1, 0549.
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in Washington, D.C., the states of AL, CA, FL, NY, OR, and VA
  • Product Description
    The Axcess Cranial Screw (sometimes referred to as the Axcess Cranial Pin) is a self-tapping, self-drilling screw and is an accessory used in conjunction with the Axcess Cranial Tri-Pin Kit. || The Axcess Bone (Cranial) Pin is intended to be used when rigid fixation of a tracking device to bone is required.
  • Manufacturer
    GE OEC Medical Systems, Inc

Manufacturer

GE OEC Medical Systems, Inc
  • Manufacturer Address
    GE OEC Medical Systems, Inc, 384 Wright Brothers Dr, Salt Lake City UT 84116-2862
  • Source
    USFDA