Recall Z-0286-2011 ยท JAK System, X-Ray, Tomography, Computed
GE Healthcare, LLC
BrightSpeed Excel/Edge/Elite Select Computed Tomography X-Ray System. For head, whole body X-ray Computed Tomography applications.
| Date | Mar 1, 2011 (initiated May 1, 2010) |
| Status | Terminated |
| Reason | Failure to properly document the CTDI in the Technical Reference or User Manual. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | Planned action(s) to repair defect or to bring product into compliance: GE Healthcare will bring the Technical Reference Manual into compliance by correcting the noncompliance in forward production and the installed base units. This will be accomplished by delivering an "Important Electronic Product Radiation Warning" letter and a TRM addendum which contains the corrected information to customers. This will be carried out via a Field Modification Instruction IFMI 229251 planned to be released in October, 2010 with an estimated completion date of April, 2011. The letter identifies the affecte |
| Quantity | 103 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.