Reported Jun 27, 2012 · Terminated

Medtronic 0-arm Imaging System with Software Version 3.1.1, Catalog Numbers: BI-700-00027-120R and BI-700-00027-120.…

Medtronic Navigation, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Medtronic Navigation, Inc. · 300 Foster St · Littleton, MA · 01460-2017

Is this the product you have?

  • Medtronic 0-arm Imaging System with Software Version 3.1.1
  • Catalog NumbersBI-700-00027-120R and BI-700-00027-120. The 0-arm¿ Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging
Lot codes and dates
  • Serial Numbers
    • 125
    • 156
    • 234R
Amount recalled
3 units

Where it was sold

Why it was recalled

Software Version 3.1.1 does not meet navigational accuracy.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 21, 2012 · Data as of Sep 19, 5:24 PM UTC

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