Millenium VG with Hawkeye/Discovery VH with Hawkeye, model number: BR321000008. GE Healthcare, Waukesha, Wisconsin 53118
FDA device recall Z-0496-2010 · posted 2010-01-21 · Terminated
Recall details
- Recalling firm
- GE Medical Systems, LLC
- Reason for recall
- Failure to provide the complete User Manual information.
- Action taken
- 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.
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 343 total
- Distribution
- Nationwide Distribution
- Date initiated
- 2009-08-01
- Date posted
- 2010-01-21
- Date terminated
- 2012-02-04
- Location
- Waukesha, WI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.