Recall Z-0832-2014 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
Brilliance iCT & Brilliance iCT SP Computed Tomography X-Ray Systems, Philips Healthcare, Cleveland, OH The Brilliance iCT and iCT SP are whole body 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. This device may include signal analysis and display equipment, patie
| Date | Jan 27, 2014 (initiated Dec 9, 2013) |
| Status | Terminated |
| Reason | Patient images exhibited ring artifacts. |
| Root cause | Software design |
| Action | The firm, Philips Healthcare, sent an "URGENT - Medical Device Correction" letter dated December 9, 2013 to their customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following to avoid the occurrence of these specific ring artifacts: 1. Disable Automatic Scan Time for all Exam Cards 2. Leave Automatic Scan Time on during planning and prior to clicking Go to initiate the scan, click the acquisition series of the scan and disable Automatic Scan Time, then proceed with the scan. 3. Disable Edit Before Final Recon (Reconstruction) f |
| Quantity | 7 units |
| Distribution | Worldwide Distribution: US (nationwide) including states of: FL, IN, NY, OR and PA; and internationally to: Australia and Israel. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060937 | BRILLIANCE VOLUME Philips Medical Systems (Cleveland), Inc., Jun 5, 2006 |