Z-0624-2009

Medtronic O-Arm Intraoperative Imaging System Catalog Number: BI-700-00027

Name: Z-0624-2009 Medtronic O-Arm Intraoperative Imaging System Catalog Number: BI-700-00027
Creator: Medtronic Navigation, Inc
Published: 2007-11-27
License: https://open.fda.gov/license/

Medtronic Navigation, Inc / initiated 2007-11-27 / Terminated / root cause: software

FDA source

Medtronic Navigation, Inc began a recall of Medtronic O-Arm Intraoperative Imaging System Catalog Number: BI-700-00027 on 2007-11-27. The reason FDA records is "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...". 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-0624-2009
Status: Terminated
Initiated: 2007-11-27
Posted: 2009-02-04
Terminated: 2016-01-22
Recalling firm: Medtronic Navigation, Inc
Product: Medtronic O-Arm Intraoperative Imaging System Catalog Number: BI-700-00027
Product code: IZL System, X-Ray, Mobile
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.
Root cause tag: software
FDA 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 in commerce: 54 units
Distribution: Worldwide Distribution: USA, Canada, Czech Republic, Denmark, Germany, Netherlands, S. Korea, Poland, South Africa, and Singapore
Product codes and lots: Software versions prior to version 3.0.2 S/N: 102-155

Product code IZL

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)