Recall Z-0928-2007 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
OEC Medical Systems, Inc
OEC Miniview 6800 mobile fluoroscopic x-ray system, GE Healthcare, Surgery, Salt Lake City, Utah.
| Date | Jul 3, 2007 (initiated May 24, 2007) |
| Status | Terminated |
| Reason | X-ray systems did not have the required labeling to indicate Air Kerma Rate and cumulative Air Kerma during fluoroscopic procedures |
| Root cause | Other |
| Action | Consignees were notified by letter on 05/24/2007 and advised that a service representative would be contacting them for installation of the required label and to provide them with an update to their user's manuals. |
| Quantity | 811 systems |
| Distribution | Worldwide; USA including VA facilities in AK, CA, ID, MD, MI, NY and OR. Military distribution to CA, CO, CT, FL, GA, KS, LA, MS, OH, OK, TX, VA and Iraq. Foreign distribution to Austria, Australia, Belgium, Canada, China, Denmark, Finland, France, Germany, Hong Kong, Israel, Italy, Japan, Korea, M |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992506 | MINI 6800 DIGITAL MOBILE C-ARM Ge Dec Medical Systems, Aug 19, 1999 |