Medtronic Navigation, Inc Medtronic O-Arm Intraoperative Imaging System Catalog Number: BI-700-00027 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Medtronic O-Arm Intraoperative Imaging System Catalog Number: BI-700-00027
Brand
Medtronic Navigation, Inc
Lot Codes / Batch Numbers
Software versions prior to version 3.0.2 S/N: 102-155
Products Sold
Software versions prior to version 3.0.2 S/N: 102-155
Medtronic Navigation, Inc is recalling Medtronic O-Arm Intraoperative Imaging System Catalog Number: BI-700-00027 due to Navigation accuracy problem: Accuracy may fall outside of specification when used in combination with the Medtronic Synergy Experience StealthStation . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026