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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare CT Systems Table Model Number 2269165

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  Class 2 Device Recall GE Healthcare CT Systems Table Model Number 2269165 see related information
Date Initiated by Firm March 12, 2009
Date Posting Updated September 25, 2009
Recall Status1 Terminated 3 on December 10, 2011
Recall Number Z-1259-2009
Recall Event ID 51879
Product Classification Computed Tomography X-Ray System - Product Code JAK
Product GE Healthcare CT Systems Table Model Number 2269165 used on LightSpeed 1X through 4X and HiSpeed Qxi CT Systems.
Code Information Tables, with associated serial numbers, built before FW20, 2002.
Recalling Firm/
GE Medical Systems, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
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.