FDA Medical Device Recalls (openFDA)
GE Medical Systems, LLC: Millenium VG with Hawkeye/Discovery VH with Hawkeye, model number: BR321000008. GE Healthcare, Waukesha, Wisconsin 53118. Generating head and whole body CT images of human subjects.
- Recall number
- Z-0496-2010
- Recalling firm
- GE Medical Systems, LLC
- Product
- Millenium VG with Hawkeye/Discovery VH with Hawkeye, model number: BR321000008. GE Healthcare, Waukesha, Wisconsin 53118. Generating head and whole body CT images of human subjects.
- Status
- Terminated
- Initiated
- 2009-08-01
- Posted
- 2010-01-21
- Terminated
- 2012-02-04
- Reason
- Failure to provide the complete User Manual information.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- A Field Modification Instruction will be released in February 2010. GE Healthcare will correct the Operator Manuals in forward production and the installed base units.
- Quantity
- 343 total
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- All serial numbers associated with model number BR321000008.
- 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