Recall Z-0496-2010 ยท JAK System, X-Ray, Tomography, Computed
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.
| Date | Jan 21, 2010 (initiated Aug 1, 2009) |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.