Recall Z-1361-2012 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
Brilliance 64 and Ingenuity CT Computed Tomography X-Ray Systems. Brilliance 64 Model# 728231, Ingenuity CT Model # 728326, Distributed By: Philips Healthcare, Cleveland, OH. The Brilliance 64 and Ingenuity CT are 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. Thes
| Date | Apr 2, 2012 (initiated Mar 12, 2012) |
| Status | Terminated |
| Reason | Philips Healthcare is performing an upgrade to the field for issues related to Philips Brilliance 64 and Ingenuity CT scanner having Software Version 3.5.1. When the user plans a scan with tilt applied, the scan increment changes from the user defined values (noncontiguous) to a contiguous scan. |
| Root cause | Software design |
| Action | . |
| Quantity | 440 units |
| Distribution | Worldwide Distribution-USA (nationwide) including the states of AK, AR, AZ, CA, CO, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MT, ND, NE, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA and WV, and the countries of Australia, Bahamas, Bangladesh, Belgium, Bolivia, Brazil, Chile, China, |
| 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 |