Recall Z-2367-2016 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
Brilliance BigBore Oncology 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.
| Date | Mar 24, 2016 |
| Status | Terminated |
| Reason | Software defect causing intermittently slow response of Host. |
| Root cause | Software change control |
| Action | On 3/24/2016 the firm mailed Customer Information letters to their customers. |
| Quantity | 8 units |
| Distribution | Product was sent to the following states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WV & WY. Product was also sent to the following countries: Algeria, Argentina, Au |
| 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 |