Events

Recall of Device Recall GE Stenographe

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

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
    49509
  • Event Risk Class
    Class 2
  • Event Number
    Z-2147-2008
  • Event Initiated Date
    2008-07-01
  • Event Date Posted
    2008-09-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73706
  • 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
    Mammographic X-Ray system - Product Code IZH
  • Reason
    Ge healthcare has recently become aware of x-ray emission beyond the edge of the detector primary barrier. this issue occurs when an exam is performed in a specific angulated view associated with use of the stereotactic positioner of your senographe ds acquisition system and could impact patient safety. if the stereotactic positioner is removed when the examination arm is at 33 degrees and, th.
  • Action
    A Product Safety Notification letter, dated March 3, 2008, was sent to affected customers. The letter provided information about the safety issue, identified affected product and stated that GE Healthcare will provide a software upgrade. Contact GE Healthcare at 1-262-544-3894 for assistance.

Device

Device Recall GE Stenographe
  • Model / Serial
    model 2405544-3, Serial numbers: 00000509762BU1, 00000509764BU7, 00000543767BU8, 00000546136BU3, 00000546140BU5, 00000546772BU5, 00000546793BU1, 00000546794BU9, 00000546799BU8, 00000550251BU3, 00000550265BU3, and 00000550266BU1.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AL, CA, CO, FL, IL, KS, MA, ME, MN,MO, NC, NJ, NM, NY OK, SC, TN, TX, and WI.
  • Product Description
    GE Stereotaxy Positioner, model 2405544-3, for use with Senographe DS Full Field Mammography system, models 2383168, 2383168-2, 2383168-3, 2383168-3-1, 2383168-4-1. The expected use of the Senographe DS Stereotaxy is an optional accessory for the Senographe system for mammography examinations.
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare
  • Manufacturer Address
    GE Healthcare, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA