Class 2 Device Recall GE CT system

• Date Initiated by Firm: October 21, 2004
• Date Posted: February 24, 2005
• Recall Status: Terminated on July 24, 2006
• Recall Number: Z-0269-05
• Recall Event ID: 30278
• 510(K)Number: K021491 K944013 K980169 K991716 K993645
• 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/ Manufacturer: 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: Other
• 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; 510(K)s with Product Code = IXR; 510(K)s with Product Code = IXR