FDA-Device2023-02-08Class II
AxiEM" Non-Invasive Patient Tracker
Medtronic Navigation, Inc.
Hazard
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.
Sold states
Worldwide - U.S. distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV. The country of Japan.
Affected count
1,867 devies
Manufactured in
826 Coal Creek Cir, N/A, Louisville, CO, United States
Products
AxiEM" Non-Invasive Patient Tracker
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1039-2023Don't want to check this manually?
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