Recall Z-0596-2017 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
Ingenuity Core 128 Computed Tomography X-ray system, Model 728323
| Date | Oct 13, 2016 |
| Status | Terminated |
| Reason | The product label does not include the correct current rating. |
| Root cause | Labeling Change Control |
| Action | The firm will send a customer letter via certified mail and will have the receipts returned for tracking purposes. Also, a Field Service Engineer will implement the Field Change Order on affected systems to resolve the issue. Implementation of the Field Change Order will be monitored. |
| Quantity | 15 |
| Distribution | Worldwide distribution. The products were shipped to the following states: AL, AZ, CO, GA, IN, KY, LA, MA, MN, NY, OH, PA, SC, TX, and UT. There are five (5) government accounts for this recall: DEPARTMENT OF VETERANS AF, VETERANS WAY AND LAMONT ST, Mountain Home, TN 37684; US ARMY EVANS COMMUNITY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160743 | Philips Ingenuity CT Philips Medical Systems (Cleveland), Inc., Aug 8, 2016 |