Recall Z-1004-2017 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
Brilliance iCT Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories
| Date | Nov 25, 2016 |
| Status | Terminated |
| Reason | Failure to correctly document the installation of four M12 Bolts into the system rotor. |
| Root cause | Employee error |
| Action | Philips sent a Customer Information Letter to their customer. The letter identified the affected product, problem description and actions to be taken by customers. For further information or support concerning this issue, contact your local Philips representative or local Philips Healthcare office. For SUPPORT North America and Canada, contact the Customer Care Solutions Center (1-800-722-9377). |
| Quantity | 1 |
| Distribution | The one system was distributed in Canada. There were no government or US distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060937 | BRILLIANCE VOLUME Philips Medical Systems (Cleveland), Inc., Jun 5, 2006 |