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 GE Healthcare CT Systems Table Model Number 2225283

  • 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 GE Healthcare CT Systems Table Model Number 2225283 see related information
Date Initiated by Firm March 12, 2009
Date Posted September 25, 2009
Recall Status1 Terminated 3 on December 10, 2011
Recall Number Z-1257-2009
Recall Event ID 51879
Product Classification Computed Tomography X-Ray System - Product Code JAK
Product GE Healthcare CT Systems Table Model Number 2225283 used on LightSpeed 1X through 4X and HiSpeed Qxi CT Systems.
Code Information All tables and serial numbers associated wtih Model Number 2225283.
Recalling Firm/
Manufacturer		 GE Medical Systems, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
262-544-3894
Manufacturer Reason
for Recall		 Failure to provide the certification label required by 21 CFR 1010.2.
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Action A GE Field Service Representative will visit each affected customer site and affix the certification label required. A Field Modification Instruction (FMI Number 25412) has been developed for release to all facilities in possession of the affected systems.
Quantity in Commerce 1179 total of all units
Distribution Nationwide Distribution
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.
-
-