AxiEM" Non-Invasive Patient Tracker
Reported: February 8, 2023 Initiated: December 15, 2022 #Z-1039-2023
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.
Details
- Recalling Firm
- Medtronic Navigation, Inc.
- Units Affected
- 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.
- Location
- Louisville, CO
Frequently Asked Questions
What product was recalled? ▼
AxiEM" Non-Invasive Patient Tracker. Recalled by Medtronic Navigation, Inc.. Units affected: 1,867 devies.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 8, 2023. Severity: Moderate. Recall number: Z-1039-2023.
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