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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 Recall
GE Healthcare CT Systems Table Model Number 2269165
see related information
Date Posted September 25, 2009
Recall Status1 Open
Recall Number Z-1259-2009
Recall Event ID 51879
Product Classification System, X-Ray, Tomography, Computed - 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/
Manufacturer
GE Medical Systems, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Consumer Instructions Contact the recalling firm for information
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: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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