Reported Jul 13, 2016 · Terminated
Medtronic 0-arm Imaging mobile x-ray system. Model Numbers - B1-700-00027, B1-700-00028
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 Street · Littleton, MA · 01460-2017
Is this the product you have?
- Medtronic 0-arm Imaging mobile x-ray system. Model Numbers - B1-700-00027, B1-700-00028
- Lot codes and dates
- Model No. BI-700-00027 and BT-700-00028
- Amount recalled
- US - 581
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
It has been discovered that replacement x-ray generator and system motion batteries could become damaged during shipment, resulting in unacceptable risk of failure.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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