Events

Recall of Device Recall EmpowerCT/EmpowerCTA Injector System Ceiling Column Accessory

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by E-Z-EM, 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
    31007
  • Event Risk Class
    Class 2
  • Event Number
    Z-0549-05
  • Event Initiated Date
    2004-12-03
  • Event Date Posted
    2005-02-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-08-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36983
  • 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, Tomography, Computed - Product Code JAK
  • Reason
    Out of specification welding could cause the ceiling mount accessory to detach from its mounting. the firm received 1 complaint from a hospital that the injector fell off the ceiling mounting bracket and landed on the floor.
  • Action
    On 12/3/04, "Urgent: Medical Device Recall" Letters (dated 12/3/04), were mailed via return receipt.

Device

Device Recall EmpowerCT/EmpowerCTA Injector System Ceiling Column Accessory
  • Model / Serial
    No lot #s or serial #s assigned to this accessory
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Medical facilities, 1 distributor & 1 physician nationwide. There were also foreign accounts in Canada, United Kingdom, France, The Netherlands and Korea.
  • Product Description
    Brand Name of Device: EmpowerCT/EmpowerCTA Injector System Ceiling Column Accessory; Common/Usual Name: CT Injector System Ceiling Column Accessory, Catalog Number 9886L. Ceiling Column Accessory: The CT and CTA Injector Systems employs an Articulating Arm that mounts to the Ceiling Column Accessory, which are designated as 9886S (11.25''), M (21.50''), and L (34.50''), i.e. 9886L.
  • Manufacturer
    E-Z-EM, Inc

Manufacturer

E-Z-EM, Inc
  • Manufacturer Address
    E-Z-EM, Inc, 750 Summa Ave, Westbury NY 11590-5040
  • Source
    USFDA