Recall Z-2145-2008 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
GE Healthcare
GE Precision RXi Digital remote X-Ray Imaging R&F System, model 5117828. GE Medical Systems - Americas, Milwaukee, USA The product is used for performing general R&F, radiology, fluoroscopy, interventional and angiography procedures/applications.
| Date | Sep 19, 2008 (initiated May 1, 2008) |
| Status | Terminated |
| Reason | The Precision RXi collimator did not contain a label identifying the device as being certified to comply with applicable requirements of the x-ray performance standard. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | GE Field Engineers will visit affected customers to make correction. |
| Quantity | 61 (32 US / 29 OUS) |
| Distribution | Within the US to include: AK, CO, IL, IN, LA, MA, MI, MS, NC, NJ, NY, PA, SC,TN, UT, VA, WA, and WI. OUS to include: Australia, Brazil, Canada, Colombia, Korea, Mexico, Philippines, Taiwan, Thailand, and Venezuela. |
| 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 |