Reported Nov 14, 2018 · Terminated
Medtronic Navigation 0-arm 02 Imaging System interventional fluoroscopic x-ray system: OARM BI70002000 SYS IMAGING 02…
Medtronic Navigation, Inc.-Littleton
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.-Littleton · 300 Foster St · Littleton, MA · 01460-2017
Is this the product you have?
- Medtronic Navigation 0-arm 02 Imaging System interventional
- fluoroscopic x-ray systemOARM
- BI70002000 SYS IMAGING 02 ModelBI70002000 OARM
- BI70002000R SYS IMAGING 02 REFURB ModelBI70002000R
- Lot codes and dates
- Serial NumbersC0875 through C2012
- Amount recalled
- 641 units
Where it was sold
- Nationwide
- PR
Why it was recalled
O-arm 02 Imaging Systems correction to software version 4.1.0; new version of the user manual and an Image Acquisition System ("IAS") product label; replacing blown fuse of the new AC power input circuit
This product could cause temporary or reversible health problems — stop using it.
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