Recall Z-0926-2013 ยท OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
Medtronic Navigation, Inc.
Medtronic O-arm Imaging System Product Usage: image-intensified fluoroscopic x-ray system, mobile
| Date | Mar 8, 2013 (initiated Jan 31, 2013) |
| Status | Terminated |
| Reason | Potential failure of the braking system that controls the O-arm Imaging System gantry movement in the vertical direction |
| Root cause | Component design/selection |
| Action | Medtronic Navigation issued a Field Safety Notice letter dated January 18, 2013 to all affected customers. The letter identified the affected product, problem, and actions to be taken. The letter instructed customers not to discontinue use and that a Medtronic Navigation Representative will be contacting them shortly to schedule a time to conduct the motion control box upgrade. For questions contact your local Medtronic Navigation representative or call Technical Services Group at 800-595-9709 or (720) 890-3200, or email at rs.navtechsupport@ medtronic.com. |
| Quantity | 463 units |
| Distribution | Worldwide Distribution - USA Nationwide and the countries of: Canada, AUSTRIA, BELGIUM, BRAZIL, BULGARIA, CHILE, CHINA, CROATIA, CZECH REPUBLIC, DENMARK,FINLAND, FRANCE, GERMANY, GREECE, INDIA, IRELAND, ISRAEL, ITALY, JAPAN ,KOREA, REPUBLIC OF KUWAIT, LEBANON, LIBYAN ARAB JAMAHIRIYA, MEXICO, NETHER |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092564 | O-ARM IMAGING SYSTEM Medtronic Navigation, Inc. (Littleton), Jun 17, 2010 |