Recall Z-0294-2008 ยท JZL
Medtronic Navigation, Inc
Medtronic 0-arm Imaging System, Product Catalog Number: B1-700-00027, Medtronic Navigation, Inc., Littleton, MA 01460 (software version 3.0)
| Date | Nov 27, 2007 (initiated Oct 17, 2007) |
| Status | Terminated |
| Reason | Reversed Instrument Position : a defect in the software version 3.0 causes an error in the position of surgical instruments and relative motion are reversed 180' on the StealthStation image. (If the StealthStation is not used, or if the patient orientation is prone or supine, the problem does not occur) |
| Root cause | Software change control |
| Action | Medtronic Navigation notified customers by letter on October 17, 2007. Medtronic Field service will perform upgrade (software version 3.0.1) at user site. |
| Quantity | 7 units |
| Distribution | Worldwide: USA including states of CO, IN, NE, and MN and countries of Canada and Germany |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050996 | O-ARM IMAGING SYSTEM Breakaway Imaging, LLC, May 5, 2005 |