FDA Medical Device Recalls (openFDA)
Medtronic Navigation, Inc: Medtronic 0-arm Imaging System, Product Catalog Number: B1-700-00027, Medtronic Navigation, Inc., Littleton, MA 01460 (software version 3.0)
- Recall number
- Z-0294-2008
- Recalling firm
- Medtronic Navigation, Inc
- Product
- Medtronic 0-arm Imaging System, Product Catalog Number: B1-700-00027, Medtronic Navigation, Inc., Littleton, MA 01460 (software version 3.0)
- Status
- Terminated
- Initiated
- 2007-10-17
- Posted
- 2007-11-27
- Terminated
- 2007-11-27
- 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
- Lot, serial or model codes
- System Serial Numbers: 103, 104, 109, 117, 119 (Germany) 125, and 144 (Canada)
- 510(k) numbers
- ["K050996"]
- PMA numbers
- not on file
- Product code
- JZL
- 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