Recall Z-0717-2008 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
GE OEC Medical Systems, Inc
GE Healthcare, Mobile Fluoroscopy X-Ray System, OEC, Model 7700, GE Healthcare, Surgery, Salt Lake City, Utah
| Date | Mar 15, 2008 (initiated Sep 28, 2007) |
| Status | Terminated |
| Reason | Unnecessary operator exposure; X-ray machine may allow unwanted x-ray exposure to the operator. |
| Root cause | Other |
| Action | On or about 9/6/2007, by Customer Notification Letter, users were notified that all affected units will be corrected by GE personnel with the addition of an additional shield. |
| Quantity | 309 systems (Domestic), 101 (Foreign) |
| Distribution | Worldwide- USA including states of CO, DE, FL, NJ, MO, NY, PA, and TX (with VA and Military facilities) and countries of Australia, Austria, Belgium, Brazil, Chile, China, The Czech Republic, Denmark, France, Germany, Hungary, Israel, Italy, Norway, Spain, Sweden, Switzerland, Thailand, and The UK |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K000221 | SERIES 7700 MOBILE C-ARM, COMPACT 7700 MOBILE C-ARM, COMPACT 7700 PLUS MOBILE C-ARM Ge Dec Medical Systems, Apr 11, 2000 |