Recall Z-1259-2009 ยท JAK System, X-Ray, Tomography, Computed
GE Medical Systems, LLC
GE Healthcare CT Systems Table Model Number 2269165 used on LightSpeed 1X through 4X and HiSpeed Qxi CT Systems.
| Date | Sep 25, 2009 (initiated Mar 12, 2009) |
| Status | Terminated |
| Reason | Failure to provide the certification label required by 21 CFR 1010.2. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | A GE Field Service Representative will visit each affected customer site and affix the certification label required. A Field Modification Instruction (FMI Number 25412) has been developed for release to all facilities in possession of the affected systems. |
| Quantity | 1179 total of all 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.