# FDA recall Z-0404-2019

> **Medtronic Navigation, Inc.-Littleton** · Class II · device recall initiated 2018-09-17.

## Product

Medtronic Navigation 0-arm 02 Imaging System interventional fluoroscopic x-ray system:    OARM BI70002000 SYS IMAGING 02  Model: BI70002000    OARM BI70002000R SYS IMAGING 02 REFURB  Model: BI70002000R

## Reason for recall

O-arm 02 Imaging Systems correction to software version 4.1.0; new version of the user manual and an Image Acquisition System ("IAS") product label; replacing blown fuse of the new AC power input circuit

## Distribution

Worldwide Distribution - US Nationwide  Foreign:  AUSTRALIA  AUSTRIA  BAHRAIN  BANGLADESH  BELGIUM  BRAZIL  CANADA  CHILE  COLOMBIA  DENMARK  FINLAND  FRANCE  GERMANY  HR  ICELAND  INDIA  IRELAND  ISRAEL  ITALY  JAPAN  JORDAN  KOREA, REPUBLIC OF  LUXEMBOURG  MARTINIQUE  MEXICO  NETHERLANDS  NEW ZEALAND  POLAND  PORTUGAL  PUERTO RICO  QATAR  SAUDI ARABIA  SINGAPORE  SOUTH AFRICA  SPAIN  SWEDEN  SWITZERLAND  TAIWAN  THAILAND  TURKEY  UNITED ARAB EMIRATES  UNITED KINGDOM

## Key facts

- **Recall number:** Z-0404-2019
- **Recalling firm:** Medtronic Navigation, Inc.-Littleton
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-09-17
- **Report date:** 2018-11-14
- **Termination date:** 2020-05-28

- **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-0404-2019

## Citation

> AI Analytics. FDA recall Z-0404-2019. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-0404-2019. Source: US FDA. Licensed CC0.

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