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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
GE Medical Systems, LLC
Lot Codes / Batch Numbers
All serial numbers associated with model number BR321000008.
Products Sold
All serial numbers associated with model number BR321000008.
GE Medical Systems, LLC is recalling Millenium VG with Hawkeye/Discovery VH with Hawkeye, model number: BR321000008. GE Healthcare, Wauke due to Failure to provide the complete User Manual information.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Failure to provide the complete User Manual information.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026