Z-0294-2008

Medtronic 0-arm Imaging System, Product Catalog Number: B1-700-00027, Medtronic Navigation, Inc., Littleton...

Name: Z-0294-2008 Medtronic 0-arm Imaging System, Product Catalog Number: B1-700-00027, Medtronic Navigation, Inc., Littleton...
Creator: Medtronic Navigation, Inc
Published: 2007-10-17
License: https://open.fda.gov/license/

Medtronic Navigation, Inc / initiated 2007-10-17 / Terminated / root cause: software

FDA source

Medtronic Navigation, Inc began a recall of Medtronic 0-arm Imaging System, Product Catalog Number: B1-700-00027, Medtronic Navigation, Inc., Littleton, MA 01460 (software version 3.0) on 2007-10-17. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0294-2008
Status: Terminated
Initiated: 2007-10-17
Posted: 2007-11-27
Terminated: 2007-11-27
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)
Product code: JZL
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)
Root cause tag: software
FDA 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 in commerce: 7 units
Distribution: Worldwide: USA including states of CO, IN, NE, and MN and countries of Canada and Germany
Product codes and lots: System Serial Numbers: 103, 104, 109, 117, 119 (Germany) 125, and 144 (Canada)

Product code JZL

K050996Class IIO-Arm Imaging SystemBreakaway Imaging, LLC / cleared 2005-05-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)