# FDA recall Z-2449-2023

> **Medtronic Navigation, Inc.-Littleton** · Class II · device recall initiated 2023-07-25.

## Product

The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients weighing 60 lbs. or greater and having an abdominal thickness greater than 16 cm and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects.

## Reason for recall

Ground cable installed incorrectly.

## Distribution

Worldwide - US Nationwide distribution in the states of CA, CO, FL, IA, IL, IN, KY, MI, MO, NC, NV, OH, TN, UT, VA, & WA. The countries of Canada, Ireland, Poland, Russian Federation, Switzerland, & Viet Nam.

## Key facts

- **Recall number:** Z-2449-2023
- **Recalling firm:** Medtronic Navigation, Inc.-Littleton
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-07-25
- **Report date:** 2023-08-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Littleton, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2449-2023

## Citation

> AI Analytics. FDA recall Z-2449-2023. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-2449-2023. Source: US FDA. Licensed CC0.

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