RecallDepth

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.

This recall has been terminated (originally issued February 24, 2005).

Company
General Electric Med Systems Llc
Recall Initiated
October 21, 2004
Posted
February 24, 2005
Terminated
July 24, 2006
Recall Number
Z-0269-05
Quantity
1150
Firm Location
Waukesha, WI
Official Source
View on FDA website ↗

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.

Lot / Code Info

Model or Catalog: 2297024, 2320315, 2244226, 2113694-2, 2115992-4, 2200290-2

Root Cause

Other

Action Taken

Inadequate materials used to manufacture the upper shaft of patient tables that can result in uncontrolled table motion.

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