Events

Recall of Device Recall Agfa Digital Radiography XRay System DXD 100

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by AGFA Healthcare 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
    68798
  • Event Risk Class
    Class 3
  • Event Number
    Z-2176-2014
  • Event Initiated Date
    2014-05-13
  • Event Date Posted
    2014-08-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-08-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128757
  • 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, mobile - Product Code IZL
  • Reason
    Unit was mislabeled with a factory label showing 32 kw output power.
  • Action
    Only one customer was affected no customer letter was issued field correction was conducted..

Device

Device Recall Agfa Digital Radiography XRay System DXD 100
  • Model / Serial
    Serial Number A5410000042
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US in the state of WV
  • Product Description
    Agfa Digital Radiography X-Ray System DX-D 100 || Product Usage: Is indicated for use in providing diagnostic quality images to aid the physician with diagnoses.
  • Manufacturer
    AGFA Healthcare Corp.

Manufacturer

AGFA Healthcare Corp.
  • Manufacturer Address
    AGFA Healthcare Corp., 10 S Academy St, Greenville SC 29601-2632
  • Manufacturer Parent Company (2017)
    Agfa-Gevaert NV
  • Source
    USFDA