FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0269-05
- Recalling firm
- General Electric Med Systems LLC
- 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.
- Status
- Terminated
- Initiated
- 2004-10-21
- Posted
- 2005-02-24
- Terminated
- 2006-07-24
- 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
- Distribution
- not on file
- Lot, serial or model codes
- Model or Catalog: 2297024, 2320315, 2244226, 2113694-2, 2115992-4, 2200290-2
- 510(k) numbers
- K021491, K944013, K980169, K991716, K993645
- PMA numbers
- not on file
- Product code
- IXR
- Firm FEI
- 2126677
- Firm city
- Waukesha
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28