Recall Z-1883-2008 ยท KPR System, X-Ray, Stationary
GE Healthcare
GE Healthcare Definium 8000 Digital Radiographic System, model number 5135678. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188 U.S.A. The intended use of this product is to generate tomographic images of human anatomy.
| Date | Sep 25, 2008 (initiated Jan 2, 2008) |
| Status | Terminated |
| Reason | Not properly labeling the manual switch for disabling positive beam limitation (PBL) located on the overhead tube support user interface as required |
| Root cause | Radiation Control for Health and Safety Act |
| Action | GE Field Engineer will visit each site to implement the correct label. Contact GE Healthcare at 1-262-544-3894 for assistance. |
| Quantity | 668 (419 US / 249 OUS) |
| Distribution | AL, CA, CO, CT, DE, FL, GA, IA,, IL,, IN, KS, LA, MA, MD, MI, MN, MO, MT, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI,WV and Washington D.C. OUS to include: Australia, Austria, Belgium, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Guyana, Hong Ko |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051967 | REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS GE Healthcare, Aug 9, 2005 |