Recall Z-0624-2009 ยท IZL System, X-Ray, Mobile
Medtronic Navigation, Inc
Medtronic O-Arm Intraoperative Imaging System Catalog Number: BI-700-00027
| Date | Feb 4, 2009 (initiated Nov 27, 2007) |
| Status | Terminated |
| Reason | Navigation accuracy problem: Accuracy may fall outside of specification when used in combination with the Medtronic Synergy Experience StealthStation System Spine Software with the O-Arm Intraoperative Imaging System and tracker. |
| Root cause | Software design |
| Action | Medtronic Navigation notified Field representatives on 11/27/07 to perform site visits to implement FCA 2007-005 - O-Arm Intraoperative Imaging System Accuracy, and deliver the Customer Letter notification. Confirmation of the visit was documented. |
| Quantity | 54 units |
| Distribution | Worldwide Distribution: USA, Canada, Czech Republic, Denmark, Germany, Netherlands, S. Korea, Poland, South Africa, and Singapore |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050996 | O-ARM IMAGING SYSTEM Breakaway Imaging, LLC, May 5, 2005 |