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U.S. Department of Health and Human Services

Class 2 Device Recall GE CT system

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  Class 2 Device Recall GE CT system see related information
Date Initiated by Firm October 21, 2004
Date Posted February 24, 2005
Recall Status1 Terminated 3 on July 24, 2006
Recall Number Z-0269-05
Recall Event ID 30278
510(K)Number K021491  K993645  K944013  K991716  K980169  
Product Classification Table, Radiographic, Tilting - Product Code IXR
Product Patient tables of CT systems with brand name: CT/e; CT/e Dual; CT/e Plus, CT/e Dual Plus; CT/e Lite; ProSpeed AI; ProSpeed AII; ProSpeed FI; ProSpeed FII; ProSpeed EII; CT HiSpeed Series.
Code Information Model or Catalog: 2297024, 2320315, 2244226, 2113694-2, 2115992-4, 2200290-2
Recalling Firm/
General Electric Med Systems LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
Manufacturer Reason
for Recall
The patient tables of the affected CT systems are supported by a hydraulic cylinder and a cylinder shaft (i.e. the upper shaft) which connects the tabletop to the table frame. GE received a report of a HiSpeed LX/I system table falling abruptly due to the filure of the upper shaft. No injuries were reported.
FDA Determined
Cause 2
Action Inadequate materials used to manufacture the upper shaft of patient tables that can result in uncontrolled table motion.
Quantity in Commerce 1150
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 = IXR and Original Applicant = GE MEDICAL SYSTEMS
510(K)s with Product Code = IXR and Original Applicant = GE MEDICAL SYSTEMS, INC.
510(K)s with Product Code = IXR and Original Applicant = GENERAL ELECTRIC CO.