FDA Medical Device Recalls (openFDA)
GE Healthcare, LLC: BrightSpeed Excel/Edge/Elite Select Computed Tomography X-Ray System. For head, whole body X-ray Computed Tomography applications.
- Recall number
- Z-0286-2011
- Recalling firm
- GE Healthcare, LLC
- Product
- BrightSpeed Excel/Edge/Elite Select Computed Tomography X-Ray System. For head, whole body X-ray Computed Tomography applications.
- Status
- Terminated
- Initiated
- 2010-05-01
- Posted
- 2011-03-01
- Terminated
- 2013-12-05
- Reason
- Failure to properly document the CTDI in the Technical Reference or User Manual.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- Planned action(s) to repair defect or to bring product into compliance: GE Healthcare will bring the Technical Reference Manual into compliance by correcting the noncompliance in forward production and the installed base units. This will be accomplished by delivering an "Important Electronic Product Radiation Warning" letter and a TRM addendum which contains the corrected information to customers. This will be carried out via a Field Modification Instruction IFMI 229251 planned to be released in October, 2010 with an estimated completion date of April, 2011. The letter identifies the affected product and describes the defect and related hazards. It also asks customers to refer to the TRM addendum for the scan time accuracy, the helical scan exposure time, and the CTDI adjustment factors for 4 and 8 slices. Contact information is also provided.
- Quantity
- 103 units
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Gantry model numbers 5191001, 5191002, 5191003, and 5191003-2.
- 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