AxiEM" Non-Invasive Patient Tracker — Class II medical device recall Z-1039-2023
Ongoing recall by Medtronic Navigation, Inc., reported 2023-02-08, distributed in AL, AR, AZ, CA, CO, DC, DE, FL…. Due to increasing complaint trend for the Non-Invasive Patient Tracker system where complaints analysis indica
| Recall number | Z-1039-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Navigation, Inc., Louisville, CO, United States |
| Recall initiated | 2022-12-15 |
| Classified | 2023-01-30 |
| Reported by FDA | 2023-02-08 |
| Distributed | 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, WV |
| Countries outside the US | JP |
| Quantity | 1,867 devies |
| UPC / GTIN / UDI-DI | 00643169608252, 00763000588380 |
| Lot numbers | 220728I, 220729 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1039-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.