Recall Z-0269-05 ยท IXR Table, Radiographic, Tilting
General Electric Med Systems LLC
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.
| Date | Feb 24, 2005 (initiated Oct 21, 2004) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | Inadequate materials used to manufacture the upper shaft of patient tables that can result in uncontrolled table motion. |
| Quantity | 1150 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021491 | HISPEED DUAL Ge Medical Systems, Inc., May 22, 2002 |
| K944013 | CT PROSPEED FAMILY GE Medical Systems, Feb 7, 1995 |
| K980169 | HISPEED LX//I, HISPEED FX/I, AND HISPEED DX/I FAMILY OF SYSTEMS General Electric Co., Apr 13, 1998 |
| K991716 | HISPEED NX/I CT SCANNER SYSTEM Ge Medical Systems, Inc., Jun 18, 1999 |
| K993645 | CT/E COMPUTED TOMOGRAPHY SCANNNER SYSTEM Ge Medical Systems, Inc., Dec 21, 1999 |