Events

Recall of Device Recall Advance Medical Equipment Cover

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Advance Medical Designs Inc.

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
    29375
  • Event Risk Class
    Class 3
  • Event Number
    Z-1036-04
  • Event Initiated Date
    2004-06-18
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-09-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33617
  • 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, Fluoroscopic, Image-Intensified - Product Code JAA
  • Reason
    The product may come apart when excessive force is applied to the coupler.
  • Action
    Consignees were notified on 6/17/2004 first by telephone on 6/17/2004 with f/u letter sent 6/18/04.

Device

Device Recall Advance Medical Equipment Cover
  • Model / Serial
    Product #04-CC900, Lot #40475C4144 and 40474C4148 *amend to include 40494C4154
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Canada
  • Product Description
    Advance¿ Medical''s, The Closed Camera System, 9'' x 96'' (23cm x 244cm), REF 04-CC900, Lot 40475C4144, Sterile, Manufactured by Advance Medical Designs, Inc., 1241 Atlanta Industrial Drive, Marietta, GA 80066 USA.
  • Manufacturer
    Advance Medical Designs Inc

Manufacturer

Advance Medical Designs Inc
  • Manufacturer Address
    Advance Medical Designs Inc, 1241 Atlanta Industrial Dr, Marietta GA 30066-6606
  • Source
    USFDA