# FDA recall Z-3161-2024

> **Carbon Medical Technologies, Inc.** · Class III · device recall initiated 2024-07-26.

## Product

BiomarC EX Fiducial Marker System, Catalog Number 040165

## Reason for recall

This recall has been initiated due to a failure to provide an MRI Insert that is to be provided to the patient.

## Distribution

US Nationwide distribution in the state of TN.

## Key facts

- **Recall number:** Z-3161-2024
- **Recalling firm:** Carbon Medical Technologies, Inc.
- **Classification:** Class III
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-07-26
- **Report date:** 2024-09-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Saint Paul, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3161-2024

## Citation

> AI Analytics. FDA recall Z-3161-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-3161-2024. Source: US FDA. Licensed CC0.

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