# FDA recall Z-0767-2020

> **Medtronic Navigation, Inc.-Littleton** · Class II · device recall initiated 2019-11-15.

## Product

O-arm" O2 Imaging System, Product Number/CFN: BI-700-02000

## Reason for recall

Due to a manufacturing issue affecting particular O-arm" O2 Imaging Systems, Medtronic has determined that the gantry tractor motor drive belt may loosen over an extended number of uses at a higher frequency in these systems. If the belt loosens, it may result in rotation of 3D images about the gantry isocenter. While the 3D image is anatomically accurate within the image itself and may be used to confirm therapy, its electronic registered location may be rotated relative to the actual physical position of the patient.

## Distribution

US: AR CA CO CT FL ID IL IN KS KY MI MN MO NC ND NE NY OH OR PA SC SD TX VA WA WI WV    OUS: AUSTRALIA CANADA CHINA FRANCE GERMANY INDIA ITALY JAPAN LEBANON NETHERLANDS ROMANIA SAUDI ARABIA SPAIN SWEDEN SWITZERLAND UNITED KINGDOM

## Key facts

- **Recall number:** Z-0767-2020
- **Recalling firm:** Medtronic Navigation, Inc.-Littleton
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-11-15
- **Report date:** 2020-01-08
- **Termination date:** 2023-09-19

- **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-0767-2020

## Citation

> AI Analytics. FDA recall Z-0767-2020. Retrieved 2026-06-04 from https://api.ai-analytics.org/recall/Z-0767-2020. Source: US FDA. Licensed CC0.

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