Events

Recall of Curix Opthos H

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
    60166
  • Event Risk Class
    Class 3
  • Event Number
    Z-0285-2012
  • Event Initiated Date
    2011-10-04
  • Event Date Posted
    2011-11-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104634
  • 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
    Film, radiographic - Product Code IWZ
  • Reason
    The film notch was located in the wrong position.
  • Action
    An "URGENT SAFETY NOTICE" letter was sent via email to the dealers on October 7, 2011. The letter describes the problem and mitigation. Acknowledgment, via FAX-Back or email, that the information was received and understood has been requested from the dealer sites. Included in each dealer letter, Agfa also provided a customer notification letter to be sent to their end-use customers. Agfa has requested dealers and end-use customers to file a complaint at 1-877-777-2432 for any identified product still in their inventories. Agfa will replace product and arrange for return shipment.

Device

Curix Opthos H
  • Model / Serial
    79890049
  • Product Classification
    Radiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, including the states of IN, KS, MI, MN, MO, NC, NE, NY, OH, and TN and the country of Canada.
  • Product Description
    Curix Opthos H, size 35x43 cm || A radiographic medical x-ray film designed to optimize diagnostic chest imaging by providing complete diagnostic information including superbly visualized lung detail along with a high level of retro-cardiac, sub-diaphragmatic and mediastinal information.
  • Manufacturer
    AGFA Corp.

Manufacturer

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