Recall Z-0001-2009 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Philips Medical Systems North America Co. Phillips
NeuViz Dual Multi-Slice Computed Tomography (CT) Scanner System (software). Whole body x-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system software is an interactive program used for x-ray scan control, image reconstruction, and image archive/evaluation. It is intended to produce cross-section
| Date | Jan 26, 2009 (initiated Apr 10, 2008) |
| Status | Terminated |
| Reason | An issue associated with the "Timed Scan" application was found. The system does not wait for the programmed time interval and starts the x-ray after selection of the scan button when certain criteria is met. |
| Root cause | Software design |
| Action | A letter was issued to customers prior to the release of the field correction during June 2008. The system software will be updated to correct the non-compliances. For information or support concerning this issue, please contact the Neusoft Medical Systems Service Support Department (helpdesk@pnms.neusoft.com) or contact Philips Medical Systems North America Co. Phillips at 425-487-7602. |
| Quantity | 19 units in the US. |
| Distribution | Nationwide Distribution --- USA including states of CO, FL, GA, IL, KY, NC, TN and TX. |
| FDA record | Open on fda.gov |