Events

Recall of Device Recall Agfa Cronex 10T

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
    34274
  • Event Risk Class
    Class 2
  • Event Number
    Z-0471-06
  • Event Initiated Date
    2005-12-21
  • Event Date Posted
    2006-02-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-04-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43402
  • 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, Film Marking, Radiographic - Product Code JAC
  • Reason
    Mislabeling; product labeled cronex¿ 10t actually contains afga, curix ultra uvl plus.
  • Action
    Consignees were first contact by telephone followed up with a certified letter, on/about 12/21/2005.

Device

Device Recall Agfa Cronex 10T
  • Model / Serial
    Catalog number LF5D1, Manufacturing Batch or Lot: 79260070
  • Product Classification
    Radiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    AZ, CA, CO, GA, IL, MI, NE, NV, OH, OR, WA and Canada
  • Product Description
    Agfa Cronex¿ 10T Radiographic film
  • Manufacturer
    AGFA Corp.

Manufacturer

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