Recall Z-1485-06 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
GE Healthcare
GE Precision RXi Digital Remote X-Ray Imaging R&F System. The Precision RXi digital is a remote R&F system consisting of a tilting table with integrated spot film device, 65 or 80 kW pulsing generator and high heat capacity X-Ray tube. The system can be configured to meet a wide variety of digital record and fluoroscopy exams for various clinical applications with either 32cm or 40cm image inten
| Date | Sep 30, 2006 (initiated Nov 1, 2006) |
| Status | Terminated |
| Reason | Automatic exposure control (AEC) automatically resets allowing another exposure without requiring manual reset as specified in 21 CFR 1020.31 (a)(3)(iv) |
| Root cause | Other |
| Action | Correction to devices is being implemented through GEHC Field Modification Instructions. |
| Quantity | 83 |
| Distribution | within US: CO, IL, LA, MA, MI, NC, PA, SC,TN, VA. OUS to include: Austrailia, Belgium, Burkina Faso, Brazil, Canada, China, Croatia, Czech Republic, Finland, France, Germany, Italy, Republic of Korea, Lebanon, Poland, Portugal, Russia, Slovakia, South Africa, Spain, Taiwan, Republic of China, Uni |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041605 | PRECISION RXI ANALOG X-RAY SYSTEM General Medical Merate S.P.A, Jun 30, 2004 |