Medtronic O-Arm Intraoperative Imaging System Catalog Number: BI-700-00027
FDA device recall Z-0624-2009 · posted 2009-02-04 · Terminated
Recall details
- Recalling firm
- Medtronic Navigation, Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IZL
- Quantity affected
- 54 units
- Distribution
- Worldwide Distribution: USA, Canada, Czech Republic, Denmark, Germany, Netherlands, S. Korea, Poland, South Africa, and Singapore
- Date initiated
- 2007-11-27
- Date posted
- 2009-02-04
- Date terminated
- 2016-01-22
- Location
- Louisville, CO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| O-ARM IMAGING SYSTEM (K050996) | Breakaway Imaging, LLC | 2005-05-05 |