Reported Aug 29, 2012 · Terminated

Medtronic O-arm¿ Imaging System. Product Numbers: BI-700-00027-100, BI-700-00027-100R, 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 O-arm¿ Imaging System
  • Product Numbers
    • BI-700-00027-100
    • BI-700-00027-100R
    • BI-700-00027-120
    • BI-700-00027-120R
    • BI-700-00027-230
    • BI-700-00027-230R
Lot codes and dates
  • Serial Numbers
    • 109R
    • 118R
    • 124
    • 136
    • 159
    • 170
    • 218
    • 222
    • 223
    • 236
    • 239
    • 299
    • 309R
    • 402
    • 410
    • 412
    • 414
Amount recalled
17 units

Where it was sold

Why it was recalled

A fault in a high voltage relay in the 0-arm¿ Imaging System might cause the relay to overheat and burn.

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 6, 2016 · Data as of Sep 19, 6:10 PM UTC

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