Events

Recall of Device Recall General Electric Seneographe

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by General Electric Med Systems.

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
    28191
  • Event Risk Class
    Class 2
  • Event Number
    Z-0285-04
  • Event Initiated Date
    2004-02-06
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-11-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31789
  • 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
    System, X-Ray, Mammographic - Product Code IZH
  • Reason
    The mammography system's information for users lacked the technical specification for the minimum filtration permanently installed in the useful beam and the technical specification for the maximum line current.
  • Action
    The consignees were sent 'Regulatory Notice' letters dated February 6, 2004. The letters informed the consignees of the violations and provided them with the technical specifications which needed to be provided.

Device

Device Recall General Electric Seneographe
  • Model / Serial
    All serial numbers
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide in the United States
  • Product Description
    Seneographe 600 Mammography X-Ray Systems (all versions)
  • Manufacturer
    General Electric Med Systems

Manufacturer

General Electric Med Systems
  • Manufacturer Address
    General Electric Med Systems, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Source
    USFDA