Recall Z-0786-2013 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
Mx8000 IDT Whole Body Computed Tomography X-ray system Distributed by Philips Medical Systems, Highland Heights, OH 44143 The Brilliance Scanner are computed Tomography X-ray systems with multi-slice capability of up to 16 slices,which are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
| Date | Feb 26, 2013 (initiated Sep 18, 2012) |
| Status | Terminated |
| Reason | The low contrast pins in the Image Quality (IQ) phantom deteriorates over time. This prevents the customers from doing the Daily Image Quality Checks as defined in the current Instructions for Use (IfU). |
| Root cause | Radiation Control for Health and Safety Act |
| Action | Philips sent a Urgent Medical Device Recall Notice letter dated September 19, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken. This issue does not effect the performance of the Scanner. The Customer Information is intended to inform you about: 1. What the problem is and under what circumstances it can occur. 2. The action you as a customer can take to minimize the effect of this problem. 3 The action planned by Philips to correct this problem. If you need any further information or support concerning this issue please contac |
| Quantity | 1,474 Units |
| Distribution | Worldwide Distribution - USA ( nationwide) including the states of AK, AL, AR, AZ, CA, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, VA, WA, WV and WY, and the countries of Albania, Algeria, Argentina, Au |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.