Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall EmpowerCT/EmpowerCTA Injector System Ceiling Column Accessorysee related information
Date Initiated by FirmDecember 03, 2004
Date PostedFebruary 16, 2005
Recall Status1 Terminated 3 on August 24, 2007
Recall NumberZ-0549-05
Recall Event ID 31007
510(K)NumberK011160 K031571 
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
ProductBrand 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 ContactMs. 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
ActionOn 12/3/04, "Urgent: Medical Device Recall" Letters (dated 12/3/04), were mailed via return receipt.
DistributionMedical facilities, 1 distributor & 1 physician nationwide. There were also foreign accounts in Canada, United Kingdom, France, The Netherlands and Korea.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JAK
-
-