—#66594

Product

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

FDA product code: IZL — System, X-Ray, Mobile
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K050996
Affected lot / code info: Software versions prior to version 3.0.2 S/N: 102-155

Why it was recalled

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 (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Medtronic Navigation, Inc
Address: 826 Coal Creek Circle, Louisville, Colorado 80027-9710

Distribution

Distribution pattern: Worldwide Distribution: USA, Canada, Czech Republic, Denmark, Germany, Netherlands, S. Korea, Poland, South Africa, and Singapore

Timeline

Recall initiated: 2007-11-27
Posted by FDA: 2009-02-04
Terminated: 2016-01-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #66594. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.