Events

Recall of CR DX-S, DX-S, Computed radiography system (Digitizer)

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
    34776
  • Event Risk Class
    Class 2
  • Event Number
    Z-0855-06
  • Event Initiated Date
    2005-11-03
  • Event Date Posted
    2006-05-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-06-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44630
  • 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
    computed radiography system digitizer - Product Code MQB
  • Reason
    Corrupted image after system start; corrupted image after workflow interruption; an erasure unit problem can cause system to stop.
  • Action
    Consignees were notified at the time of upgrading. The software was upgraded on 11/3/2005, 12/19/2005 and 12/28/2005. A Mandatory Service Bulletin, No. 11, explaining the issues was shared with the accounts.

Device

CR DX-S, DX-S, Computed radiography system (Digitizer)
  • Model / Serial
    CR DX-S: Units with Serial numbers SN1001-SN1079, Software versions: STR1102B and below.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    DC, MS, OR--three states
  • Product Description
    CR DX-S, DX-S, Computed radiography system (Digitizer)
  • Manufacturer
    AGFA Corp.

Manufacturer

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