Recall Z-1646-2013 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
Computed Tomography X-ray systems Product Usage: The Brilliance CT 64, Ingenuity Core, and Ingenuity Core128 scanners are whole body Computed Tomography X-ray systems that are 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, an
| Date | Jul 2, 2013 (initiated Apr 15, 2013) |
| Status | Terminated |
| Reason | Philips Healthcare received reports from the field that certain Brilliance CT 64, Ingenuity Core, and Ingenuity Core128 systems running software versions 2.6.1 or 3.5.4 exhibited intermittent swirl-like ring artifacts that may appear on reconstructed images, which may impair the diagnostic quality of affected images. |
| Root cause | Software design |
| Action | Philips Healthcare sent an Urgent Medical device Correction letter dated April 15, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter states that Philips Healthcare is implementing software update versions 2.6.2 or 3.5.5 to resolve the issue and a Philips Field Service Engineer will contact each site to schedule the software installation. For questions contact your local Philips representative or local Philips Healthcare office. |
| Quantity | 2348 total units: 2182 Brilliance CT 64 units; 95 Ingenuity Core units; and 71 Ingenuity Core128 units. |
| Distribution | USA Nationwide Distribution - including the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. |
| 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 |