Events

Recall of Device Recall DXD Imaging Package

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
    61052
  • Event Risk Class
    Class 2
  • Event Number
    Z-1062-2012
  • Event Initiated Date
    2012-01-16
  • Event Date Posted
    2012-02-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107178
  • 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
    Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
  • Reason
    The firm received a complaint that when using the dx-d mobile dr x-ray unit they noticed the detector cable was hot.
  • Action
    AGFA Corp. sent an "URGENT FIELD SAFETY NOTICE" letter dated January 16, 2012 to affected consignees. The letter described the affected product, concerns, issues and actions to be taken. Customers have been requested to place the Varian warning label included in a highly visible and suitable position on the cable of the portable detector. Customers were instructed to complete and return the feedback form by fax to 864-421-1664, as soon as possible. For questions about this matter contact your local AGFA HealthCare Technical Support at 877-777-2432.

Device

Device Recall DXD Imaging Package
  • Model / Serial
    Model Numbers DX-D 20G and DX-D 20C; Catalog Numbers ABC Code 5PYTM and 5PYUO
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution (USA) including the states of: FL, IL, IN, KS, MI, MN, MS, NE,NY, OH, SC and WV.
  • Product Description
    Agfa DX-D Imaging Package - (The detector power cables described in the Report of Correction and Removal are connected to portable detector panels used in the DX-D systems) || Product Usage: || DX-D Imaging Package ha the same intended use as the predicative devices: namely to provide diagnostic quality images to aid the physician with diagnosis. The device uses Agfas fla panel detectors with amorphous silicon scintillators and NX workstations with MUSICA imaeg processing to create radiographic images of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts. The product is not indicated for use in mammography.
  • Manufacturer
    AGFA Corp.

Manufacturer

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