Medtronic O-Arm Intraoperative Imaging System Catalog Number: BI-700-00027
FDA Recall Z-0624-2009 · Posted 2009-02-04
Recalling FirmMedtronic Navigation, Inc
Recall StatusTerminated
Product CodeIZL
Date Initiated2007-11-27
Date Terminated2016-01-22
Product Quantity54 units
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.
Firm 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.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution: USA, Canada, Czech Republic, Denmark, Germany, Netherlands, S. Korea, Poland, South Africa, and Singapore
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.