Recall Z-1849-2012 ยท IZL System, X-Ray, Mobile
Medtronic Navigation, Inc.
Medtronic 0-arm Imaging System with Software Version 3.1.1, Catalog Numbers: BI-700-00027-120R and BI-700-00027-120. The 0-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging.
| Date | Jun 21, 2012 (initiated Oct 12, 2010) |
| Status | Terminated |
| Reason | Software Version 3.1.1 does not meet navigational accuracy. |
| Root cause | Software design |
| Action | Medtronic Navigation contacted customers by telephone on 10/12/2010 and with "Urgent Field Safety Notice" follow up letters dated 10/14 or 10/15/2010. Sites were visited by Medtronic Service Representative to complete navigational accuracy testing and either replace or correct the unit. |
| Quantity | 3 units |
| Distribution | Nationwide Distribution including the states of CO, IN, and MN. |
| 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 |