FDA Medical Device Recalls (openFDA)
GE Medical Systems, LLC: GE Healthcare CT Systems Table Model Number 2269165 used on LightSpeed 1X through 4X and HiSpeed Qxi CT Systems.
- Recall number
- Z-1259-2009
- Recalling firm
- GE Medical Systems, LLC
- Product
- GE Healthcare CT Systems Table Model Number 2269165 used on LightSpeed 1X through 4X and HiSpeed Qxi CT Systems.
- Status
- Terminated
- Initiated
- 2009-03-12
- Posted
- 2009-09-25
- Terminated
- 2011-12-10
- Reason
- Failure to provide the certification label required by 21 CFR 1010.2.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- A GE Field Service Representative will visit each affected customer site and affix the certification label required. A Field Modification Instruction (FMI Number 25412) has been developed for release to all facilities in possession of the affected systems.
- Quantity
- 1179 total of all units
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Tables, with associated serial numbers, built before FW20, 2002.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JAK
- 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