Recall Z-1359-2015 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
Computed Tomography X-ray Systems (Brilliance CT 64-channel w/Essence technology, Brilliance iCT, Brilliance iCT SP, Ingenuity Core, Ingenuity Core128 & Ingenuity CT), Philips Medical Systems, Cleveland, OH
| Date | Apr 1, 2015 (initiated Feb 5, 2015) |
| Status | Terminated |
| Reason | Philips discovered that a software defect exists in marketed product wherein the sign indication of the longitudinal position of some types of scan is inverted. |
| Root cause | Software design |
| Action | Philips sent an Customer Information letter dated February 5, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. They informed their customers that they should refrain from using Multi Planar Reconstruction (MPR) derived images for identifying the absolute position of the intervention for feet-first patient orientation. A Philips Field Service Engineer will contact you to schedule the software installation at your site. If you need any further information or support concerning this issue, please contact your loca |
| Quantity | 424 units |
| Distribution | Worldwide Distribution - Nationwide Distribution to the states of : AR, AZ, CA, CT, DE, FL, GA, IA, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VT, WV and WY., and to the countries of : Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Canada, Cambo |
| FDA record | Open on fda.gov |