Events

Recall of Mammography Keypad

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

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
    57110
  • Event Risk Class
    Class 3
  • Event Number
    Z-0835-2011
  • Event Initiated Date
    2010-10-22
  • Event Date Posted
    2010-12-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-02-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95407
  • 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, image processing, radiological - Product Code LLZ
  • Reason
    Product did not receive ul certification.
  • Action
    AGFA sent an Urgent Safety Notice letter dated October 22, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customers. Customers were instructed to unplug existing keypad(s)  including USB cable. Plug in loaner Keypad(s). Print out the Fed Ex shipping label that they received via the e-mail notification. Use that label to ship their existing keypad(s) and their corresponding USB cables to the manufacturer. The manufacturer would perform the upgrades and return the keypad(s) along with the USB cables. Upon receipt of the original keypad(s) customers would also receive another e-mail notification with a shipping label so that they may return the loaner keypad(s) to AGFA HealthCare. Customers were to distribute this information to all those who need to be aware of it, and complete the feedback form as soon as possible and return it to AGFA HealthCare. For questions regarding this recall call 838-342-3989. .

Device

Mammography Keypad
  • Model / Serial
    504RU000
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldlwide Distribution - USA including FL, GA, KY, ME, MD, MS, OH, UT and the country of Canada
  • Product Description
    Mammography Keypad || Radiologists and Technologist apply hotkeys from a keyboard for ease of use in their clinical and diagnostic activities. The Agfa Mammography Keypad allows users the ability to apply hot keys from a keypad versus a keyboard.
  • Manufacturer
    AGFA Corp.

Manufacturer

AGFA Corp.
  • Manufacturer Address
    AGFA Corp., 10 S Academy St, Greenville SC 29601-2632
  • Source
    USFDA