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; ProSpe
FDA device recall Z-0269-05 · posted 2005-02-24 · Terminated
Recall details
- Recalling firm
- General Electric Med Systems LLC
- 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.
- Action taken
- Inadequate materials used to manufacture the upper shaft of patient tables that can result in uncontrolled table motion.
- Root cause
- Other
- Status
- Terminated
- Product code
- IXR
- Quantity affected
- 1150
- Date initiated
- 2004-10-21
- Date posted
- 2005-02-24
- Date terminated
- 2006-07-24
- Location
- Waukesha, WI
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HISPEED DUAL (K021491) | Ge Medical Systems, Inc. | 2002-05-22 |
| CT/E COMPUTED TOMOGRAPHY SCANNNER SYSTEM (K993645) | Ge Medical Systems, Inc. | 1999-12-21 |
| HISPEED NX/I CT SCANNER SYSTEM (K991716) | Ge Medical Systems, Inc. | 1999-06-18 |
| HISPEED LX//I, HISPEED FX/I, AND HISPEED DX/I FAMILY OF SYSTEMS (K980169) | General Electric Co. | 1998-04-13 |
| CT PROSPEED FAMILY (K944013) | GE Medical Systems | 1995-02-07 |