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U.S. Department of Health and Human Services

Class 2 Device Recall EmpowerCT/EmpowerCTA Injector System Ceiling Column Accessory

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  Class 2 Device Recall EmpowerCT/EmpowerCTA Injector System Ceiling Column Accessory see related information
Date Initiated by Firm December 03, 2004
Date Posted February 16, 2005
Recall Status1 Terminated 3 on August 24, 2007
Recall Number Z-0550-05
Recall Event ID 31007
510(K)Number K011160  K031571  
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
Product 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.
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

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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