# FDA recall Z-2707-2020

> **Medtronic Navigation, Inc.** · Class II · device recall initiated 2020-06-05.

## Product

StealthStation" S7 System with Polaris Spectra Camera part number PSU 9733437 - Product Usage: are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures.

## Reason for recall

There is a potential for specific camera units to be affected by a characterization issue during manufacturing that results in inaccurate navigation while utilizing both the active and passive trackers simultaneously. While no injuries or illnesses have been reported,  If impacted cameras were to be used with both active and passive trackers simultaneously, it would result in system navigation inaccuracy of 6mm.

## Distribution

US Nationwide distribution including in the states of Alabama and Massachusetts.

## Key facts

- **Recall number:** Z-2707-2020
- **Recalling firm:** Medtronic Navigation, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-06-05
- **Report date:** 2020-08-05
- **Termination date:** 2024-05-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Louisville, CO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2707-2020

## Citation

> AI Analytics. FDA recall Z-2707-2020. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-2707-2020. Source: US FDA. Licensed CC0.

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