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
125156234R
- Serial Numbers
- 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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