Date Initiated by Firm |
December 03, 2004 |
Date Posted |
February 16, 2005 |
Recall Status1 |
Terminated 3 on August 24, 2007 |
Recall Number |
Z-0549-05 |
Recall Event ID |
31007 |
510(K)Number |
K011160 K031571
|
Product Classification |
System, X-Ray, Tomography, Computed - Product Code JAK
|
Product |
Brand Name: EmpowerCT/EmpowerCTA Injector System Ceiling Column Accessory; Common/Usual Name: CT Injector System Ceiling Column Accessory, Catalog Number 9886M. 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. |
Code Information |
No lot #s or serial #s assigned to this accessory |
Recalling Firm/ Manufacturer |
E-Z-EM, Inc 750 Summa Ave Westbury NY 11590-5040
|
For Additional Information Contact |
Ms. Tracey A. Campbell 516-333-8230 Ext. 2307
|
Manufacturer Reason for Recall |
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.
|
FDA Determined Cause 2 |
Other |
Action |
On 12/3/04, "Urgent: Medical Device Recall" Letters (dated 12/3/04), were mailed via return receipt. |
Distribution |
Medical facilities, 1 distributor & 1 physician nationwide. There were also foreign accounts in Canada, United Kingdom, France, The Netherlands and Korea. |
Total Product Life Cycle |
TPLC Device Report
|
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = JAK and Original Applicant = E-Z-EM, INC.
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