FDA Medical Device Recalls (openFDA)
Medtronic Navigation, Inc: Medtronic O-Arm Intraoperative Imaging System Catalog Number: BI-700-00027
- Recall number
- Z-0624-2009
- Recalling firm
- Medtronic Navigation, Inc
- Product
- Medtronic O-Arm Intraoperative Imaging System Catalog Number: BI-700-00027
- Status
- Terminated
- Initiated
- 2007-11-27
- Posted
- 2009-02-04
- Terminated
- 2016-01-22
- 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
- Lot, serial or model codes
- Software versions prior to version 3.0.2 S/N: 102-155
- 510(k) numbers
- ["K050996"]
- PMA numbers
- not on file
- Product code
- IZL
- Firm FEI
- 1000517638
- Firm city
- Louisville
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28