Cl Il Medtronic O-Arm Intraoperative Imaging Sys

Company:Medtronic Navigation, Inc
Date of Enforcement Report 2/11/2009
Class:ll

PRODUCT
Medtronic O-Arm Intraoperative Imaging System, Catalog number: Bl-700-0027, Recall # Z-0624-2009

REASON
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.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Navigation, Inc., Louisville, CO, by site visits on November 27, 2007.
Manufacturer: Medtronic Navigation, Inc., Littleton, MA. Firm initiated recall is complete.

VOLUME OF PRODUCT IN COMMERCE
54 units

DISTRIBUTION
Nationwide, Canada, Czech Republic, Denmark, Germany, Netherlands, South Korea, Poland, South Africa, and Singapore

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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