Recall Z-0974-2017 ยท OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
GE OEC Medical Systems, Inc
OEC MiniView 6800. MDL Number: D002533 The OEC MiniView 6800 Digital Mobile C-Arm is designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imaging. The device is not intended for whole-body pediatric imaging
| Date | Jan 9, 2017 (initiated Dec 19, 2016) |
| Status | Terminated |
| Reason | GE Healthcare Surgery announces a voluntary field action for the OEC MiniView 6800, OEC 9900 Elite, and OEC 9800 because the workstation power cable assembly can result in intermittent power cord failures. |
| Root cause | Use error |
| Action | GE Healthcare sent an Urgent Medical Device Correction letter dated December 19, 2016, to all affected consignees. GE informed consignees that GE will correct all affected products. If consignnes have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or their local Service Representative. For questions regarding this recall call 801-536-4952. |
| Distribution | Worldwide Distribution - US including U.S. States: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PUERTO RICO, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Internationally to Canada, Mexico, an |
| 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 |