07
Dec
2007

Inc, Cl II Medtronic Navigation

0

Company: Medtronic Navigation, Inc
Date of Enforcement Report:12/5/2007
Class:ll

PRODUCT
Medtronic 0-arm Imaging System, Product Catalog Number: B1-700-00027, (software version 3.0), Recall # Z-0294-2008

REASON
Reversed Instrument Position: a defect in the software version 3.0 causes an error in the position of surgical instruments and relative motion are reversed 180′ on the StealthStation image. (If the StealthStation is not used, or if the patient orientation is prone or supine, the problem does not occur)

RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Navigation, Inc., Louisville, CO, by letter on October 17, 2007.
Manufacturer : Medtronic Navigation, Inc., Littleton, MA.

VOLUME OF PRODUCT IN COMMERCE
7 units

DISTRIBUTION
Nationwide and Internationally

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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