Recall Z-0236-2015 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems, Inc.
Philips Brilliance iCT Computed Tomography X-Ray System Product Usage: The Brilliance iCT/Brilliance iCT SP is a Computed Tomography X-Ray System intended to produce crosssectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. (d) A description of the defect in the
| Date | Dec 16, 2014 (initiated Jul 31, 2014) |
| Status | Terminated |
| Reason | It was discovered that a software defect may result in the scanner not terminating the CT scan at the intended location. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | Philips Healthcare is directly notifying affected users via letter. In addition, Philips Healthcare has performed the software correction for forward production and plans a Field Correction to fix the defect in the field. If you need any further information or support concerning this issue, please contact your local Philips representative or local Philips Healthcare office. |
| Quantity | 16 systems |
| Distribution | 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 |