Recall Z-1369-2012 ยท KPS System, Tomography, Computed, Emission
Philips Medical Systems (Cleveland) Inc
GEMINI TF 16, 64 & Big Bore Computed Tomography X-Ray Systems, M/N 882470, 882471 & 882476, Distributed by: Philips Medical System, Cleveland, OH Product Usage: The Computed Tomography X-Ray 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. These devices may include signal analysis and d
| Date | Apr 5, 2012 (initiated Jan 26, 2012) |
| Status | Terminated |
| Reason | TumorLOC will save the incorrect contour when the user saves the contour while in the edit mode, and the software does not force the user to exit the edit mode before saving. In TumorLOC, when saving while a contour is in edit mode, that contour will shift to the slice corresponding to the most recently drawn contour of the last organ in the Organ list. |
| Root cause | Software design (manufacturing process) |
| Action | Philips sent an Urgent - Medical Device Correction letters to all affected customers. The letter identified the product, what the problem is and under what circumstances it can occur, important information for the continued safe and proper use of the affected equipment, and actions to be taken to minimize the effect of the problem. Philips instructed their customers to put a copy of the letter with their "Instructions for Use" manual. For question contact your local Philips representative or local philips healthcare office. For North America and Canada contact the Customer Care Solutions |
| Quantity | 289 units |
| Distribution | Worldwide Distribution - USA (nationwide) including the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV & WY. Product was also shipped to the fol |
| FDA record | Open on fda.gov |