# FDA recall Z-1039-2023

> **Medtronic Navigation, Inc.** · Class II · device recall initiated 2022-12-15.

## Product

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.

## 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.

## Key facts

- **Recall number:** Z-1039-2023
- **Recalling firm:** Medtronic Navigation, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-12-15
- **Report date:** 2023-02-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Louisville, CO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1039-2023

## Citation

> AI Analytics. FDA recall Z-1039-2023. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-1039-2023. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*