Events

Recall of Device Recall IMPAX Network Gateway Server, License Key

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
    46812
  • Event Risk Class
    Class 2
  • Event Number
    Z-1306-2008
  • Event Initiated Date
    2007-12-11
  • Event Date Posted
    2008-07-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-07-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68301
  • 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 image communications device - Product Code LMD
  • Reason
    Failure of data transmission: no imaging data could be transmitted by the device, because a key value needed for data transmission was incorrectly entered in the affected units by agfa healthcare.
  • Action
    On 12/11/07, AGFA Healthcare sent out an e-mail to all affected consignees informing them of the situation. The firm also arranged to install the corrected License Key on all affected units of the product.

Device

Device Recall IMPAX Network Gateway Server, License Key
  • Model / Serial
    ABC Code EXEGE000
  • Product Classification
    Radiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution - USA, including states of CA, GA, IA and SD.
  • Product Description
    IMPAX¿ 6.2.1 Network Gateway Server, License Key. Catalog # ABC code: EXEGE000. The product is used to transfer medical imaging data. AGFA Corp., Greenville, South Carolina 2960.
  • Manufacturer
    AGFA Corp.

Manufacturer

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