Medtronic 0-arm Imaging System, Product Catalog Number: B1-700-00027, Medtronic Navigation, Inc., Littleton, MA 01460 (s
FDA device recall Z-0294-2008 · posted 2007-11-27 · Terminated
Recall details
- Recalling firm
- Medtronic Navigation, Inc
- Reason for recall
- 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)
- Action taken
- Medtronic Navigation notified customers by letter on October 17, 2007. Medtronic Field service will perform upgrade (software version 3.0.1) at user site.
- Root cause
- Software change control
- Status
- Terminated
- Product code
- JZL
- Quantity affected
- 7 units
- Distribution
- Worldwide: USA including states of CO, IN, NE, and MN and countries of Canada and Germany
- Date initiated
- 2007-10-17
- Date posted
- 2007-11-27
- Date terminated
- 2007-11-27
- Location
- Louisville, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| O-ARM IMAGING SYSTEM (K050996) | Breakaway Imaging, LLC | 2005-05-05 |