Recall Z-1143-2019 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
Brilliance 64, 728231 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. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories
| Date | Jul 3, 2018 |
| Status | Terminated |
| Reason | Philips has identified that the compensator within the X-ray tube collimator may fail, resulting in ring or smudge artifacts on images. The firm has identified systems that may be at risk for this failure due to the collimator compensator being past its lifetime expected usage. |
| Root cause | Device Design |
| Action | On June 29. 2018, the firm sent Customer Information Letters to affected customers. The letter informed customers that Philips has identified that the compensator within the X-ray tube collimator may fail, resulting in ring or smudge artifacts on images. Customers were advised to review the user documentation provided with your system related to Quality Assurance checks. If artifacts are detected during review of the images produced by these checks, and are not removed with the recommended steps identified within your user documentation, please contact your service representative before resum |
| Quantity | 14 |
| Distribution | Distributed only to China and UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033326 | PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM Philips Medical Systems, Inc., Oct 29, 2003 |