Events

Recall of Device Recall Curix

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
    34890
  • Event Risk Class
    Class 3
  • Event Number
    Z-0755-06
  • Event Initiated Date
    2006-02-16
  • Event Date Posted
    2006-04-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-06-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44894
  • 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
    Medical Screen X-Ray Film - Product Code JAC
  • Reason
    A localized fog pattern appears on the film.
  • Action
    Consignees were notified by telephone on 02/16/2006.

Device

Device Recall Curix
  • Model / Serial
    Product Code; EKQEG, Manufacturing Batch or Lot: 79340029
  • Product Classification
    Radiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    AL, AZ, CA, CO, FL, GA, IN, MA, MI, NC, NJ, NY, OR, SC, TN, TX, WA, VA and Canada
  • Product Description
    Curix¿ Ultra UV-L Plus, Medical Screen Film, X-ray Film, 14x17, 100 Sheet Box
  • Manufacturer
    AGFA Corp.

Manufacturer

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