Recall Z-0955-2015 ยท JAK System, X-Ray, Tomography, Computed
GE Healthcare
The Revolution CT is a multi-slice (256 detector row) CT scanner consisting of a gantry, patient table, scanner desktop (operator console), system cabinet, power distribution unit (POU). and interconnecting cables.The system includes image acquisition hardware, image acquisition and reconstruction software, and associated accessories.
| Date | Jan 26, 2015 (initiated Nov 12, 2014) |
| Status | Terminated |
| Reason | A required quality control test was not performed during installation associated with the software of the Revolution CT scanner. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | GE Healthcare Planned Action (s) to repair defect or to bring product into Compliance letter dated January 16, 2015 to GE Healthcare. 1. A GE Healthcare service representative will perform a noise specification and tolerance calibration to correct all affected systems via Field Action Instruction (FMI 25457). 2. A customer notification letter which includes a statement that GE Healthcare will without charge, remedy the defect or bring the product into compliance. CDRH approves the CAP subject to the following conditions: 1. Notification of all dealers and purchasers is to be made within 15 |
| Quantity | 13 units |
| Distribution | US Distribution to the states of CA, FL, IL, NY, UT and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133705 | REVOLUTION CT Ge Medical Systems, LLC, Apr 11, 2014 |