Recall Z-0831-2014 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
Brilliance iCT and Brilliance iCT SP These systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. May include signal analysis and display equipment, patient and equipment supports, components and accessories
| Date | Jan 27, 2014 (initiated Jul 16, 2013) |
| Status | Terminated |
| Reason | An artifact that resembles thrombus may appear on the image. |
| Root cause | Device Design |
| Action | Philips sent an Field Safety Notice dated July 15, 2013, to all US customers via certified mail. Market representatives will distribute the letter internationally. The letter identified the product the problem and the action needed to be taken by the customers. Additionally, a Field Service Engineer will contact each site to schedule a time to implement the Field Change Order. If you need any further information or support concerning this issue, please contact your local Philips representative or local Philips Healthcare office.For North America and Canada, contact the Customer Care Solut |
| Quantity | 506 |
| Distribution | Worldwide Distribution - USA (nationwide) including Puerto Rico and the states AL, AR, AZ, CA, DC, DE, FL, GA, IA, IL, IN, KY, MA, MD, MN, MO, MS, NC, NV, NY, OH, OK, OR, PA, SC, TX, VT, WA, and WV., and the countries of Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belgium, Brazil, Chil |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060937 | BRILLIANCE VOLUME Philips Medical Systems (Cleveland), Inc., Jun 5, 2006 |