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Terminated

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.

FDA Recall Z-0269-05 · Posted 2005-02-24

Recalling FirmGeneral Electric Med Systems LLC
Recall StatusTerminated
Product CodeIXR
Date Initiated2004-10-21
Date Terminated2006-07-24
Product Quantity1150

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.

Firm Action

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

Root Cause

Other

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K021491HISPEED DUALGe Medical Systems, Inc. · 2002-05-22K993645CT/E COMPUTED TOMOGRAPHY SCANNNER SYSTEMGe Medical Systems, Inc. · 1999-12-21K991716HISPEED NX/I CT SCANNER SYSTEMGe Medical Systems, Inc. · 1999-06-18K980169HISPEED LX//I, HISPEED FX/I, AND HISPEED DX/I FAMILY OF SYSTEMSGeneral Electric Co. · 1998-04-13K944013CT PROSPEED FAMILYGE Medical Systems · 1995-02-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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