Reported Mar 20, 2013 · Terminated
Medtronic O-arm Imaging System Product Usage: image-intensified fluoroscopic x-ray system, mobile
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 Usageimage-intensified fluoroscopic x-ray system, mobile
- Lot codes and dates
- Product Catalog Numbers9732719, 9732719R, 9733346, 9733346R, BI-700-00027, BI-700-00027R, BI-700-00027-GER, BI-700-00027-GERR, BI-700-00027-100, BI-700-00027-100R, BI-700-00027-120, BI-700-00027-120R, BI-700-00027-230, BI-700-00027-230R Units with serial numbers 101 through 564 and unit 580 are affected. Serial numbers 565 and higher are not affected
- Amount recalled
- 463 units
Where it was sold
- Nationwide
Why it was recalled
Potential failure of the braking system that controls the O-arm Imaging System gantry movement in the vertical direction
This product could cause temporary or reversible health problems — stop using it.
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