AxiEM" Non-Invasive Patient Tracker
FDA Recall #Z-1039-2023 — Class II — December 15, 2022
Product Description
AxiEM" Non-Invasive Patient Tracker
Reason for Recall
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.
Recalling Firm
Medtronic Navigation, Inc. — Louisville, CO
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
1,867 devies
Distribution
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.
Code Information
Product Number/CFN: 9734887XOM UDI-Device Identifier (GTIN/UPN): 00763000588380 Lot Number: 220728I 220729 Product Number/CFN: 9734887XOM UDI-Device Identifier (GTIN/UPN): 00643169608252 Lot Number: 220728I
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated