Recall Z-0473-2015 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
IntelliSpace Portal DX/HX/EX model number: 881001 IntelliSpace Portal DX/HX/EX Upgrade model number: 881011 IntelliSpace Portal DX/HX/EX Demo model number: 881012 IntelliSpace Portal IX model number; 881030 System, x-ray, tomography, computed
| Date | Dec 1, 2014 (initiated Nov 9, 2014) |
| Status | Terminated |
| Reason | Software defect. In certain circumstances, the application may display incorrect measurements of cardiac and aortic anatomy used to select and size the Transcatheter heart valve (THV) to be implanted . |
| Root cause | Software design |
| Action | Consignees were notified of the Field Safety Notice via certified mail. |
| Quantity | 32 |
| Distribution | Worldwide Distribution: US Distribution in states of: FL, NC, and VT; and the countries of Argentina, Austria, Belgium, Canada, Denmark, France, India, Italy, Japan, Netherlands, United Kingdom, and Vietnam. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132524 | CT TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PLANNING APPLICATION Philips Medical Systems, Jun 13, 2014 |