Recall Z-2666-2014 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
The Brilliance CT Big Bore is a whole-body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data from the same axial plane taken at different angles. Model Numbers 728244 and 728243.
| Date | Sep 18, 2014 (initiated Aug 31, 2012) |
| Status | Terminated |
| Reason | Philips Healthcare received a complaint stating the system opens e-stop while sitting idle causing all movements and scan to stop. The problem has only occurred one time when the scan was out of Ready for Scan or scanning mode. |
| Root cause | Software design |
| Action | A Customer Letter (FSN 72800580), Attachment #1, will be sent to all US and Canadian consignees via certified mail. Philips Key Market representatives will distribute the letter internationally. Additionally, a Field Service Engineer will contact each site to schedule time to implement the Field Change Order. |
| Quantity | 257 |
| Distribution | Nationwide Distribution incuding states of: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, MS, NC, ND, NH, NJ, NM, NY, OH, OK, OR, PA, TN, TX, VA, WA, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033357 | ACQSIM-MULTISLICE-CT, MODEL 453567042271 Philips Medical Systems (Cleveland), Inc., Jan 9, 2004 |