Reported Mar 12, 2014 · Terminated
Medtronic O-arm Imaging System Mobile X-ray system. Model No. BI-700-00027 and BI-700-00028 The 0-arm Imaging System is…
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 Mobile X-ray system. Model No. BI-700-00027 and BI-700-00028 The 0-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The 0-ann Imaging System is compatible with certain Image Guided Surgery Systems.
- Lot codes and dates
- Model No. BI-700-00027
- and BI-700-00028 Serial number range
00102 through 00753 and B13080721B13080722B13090729B13120763B13120764B13120766B13120768B13120769
- Amount recalled
- 449 in US
Where it was sold
- Nationwide
Why it was recalled
Review of on-system electronic product labeling and Instructions for comply with applicable Use in response to a customer inquiry uncovered gaps in compliance FDA standards with the requirements for information to be provided to users in 21CFR 1020.30(h)
This product could cause temporary or reversible health problems — stop using it.
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