Recall Z-0494-2010 ยท JAK System, X-Ray, Tomography, Computed
GE Medical Systems, LLC
Infinia with Hawkeye 1, model numbers: H2508PW, H2508PY, H3000WN, H3000WR, H3000WW, H3000WY, H3000WZ, H3000YM, and H3000YS. 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.