Events

Recall of Device Recall Digital mammography system.

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

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
    34975
  • Event Risk Class
    Class 2
  • Event Number
    Z-0757-06
  • Event Initiated Date
    2006-03-27
  • Event Date Posted
    2006-04-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45051
  • 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
    Digital mammography system. - Product Code MUE
  • Reason
    Software upgrade to preclude lost images during mammography procedure.
  • Action
    Consignees were notified by letter on 03/27/2006.

Device

Device Recall Digital mammography system.
  • Model / Serial
    Software versions earlier than 5.2.2  Product Number 94001G-3, 105200G
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide. AZ, CA, CO, FL, GA, IL, IN, KS, MA, MI, MN, MT, NY, OK, SC, TX, WA, WI, WV. No government or military consignees.
  • Product Description
    SenoScan Full Field Digital Mammography System--Product Number 94001G-3, 105200G
  • Manufacturer
    Fischer Imaging Corporation

Manufacturer

Fischer Imaging Corporation
  • Manufacturer Address
    Fischer Imaging Corporation, 12300 North Grant Street, Denver CO 80241-3120
  • Source
    USFDA