Reported Feb 8, 2023 · Ongoing
AxiEM" Non-Invasive Patient Tracker
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. · 826 Coal Creek Cir · Louisville, CO · 80027-9710
Is this the product you have?
- AxiEM" Non-Invasive Patient Tracker
- Lot codes and dates
- Product Number/CFN9734887XOM
- UDI-Device Identifier (GTIN/UPN)00763000588380
- Lot Number220728I 220729
- Product Number/CFN9734887XOM
- UDI-Device Identifier (GTIN/UPN)00643169608252
- Lot Number220728I
- Amount recalled
- 1,867 devies
Where it was sold
Why it was recalled
Due to increasing complaint trend for the Non-Invasive Patient Tracker system where complaints analysis indicates that users are unable to successfully verify their navigation instruments during image-guided surgery.
This product could cause temporary or reversible health problems — stop using it.
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