# FDA recall Z-1590-2026

> **GE Medical Systems, LLC** · Class II · device recall initiated 2026-02-03.

## Product

Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E85101LP

## Reason for recall

There is a potential issue that can lead to discordance between the simulated needle trajectory/tip position and the actual needle trajectory/tip position.

## Distribution

Worldwide distribution - US Nationwide.

## Key facts

- **Recall number:** Z-1590-2026
- **Recalling firm:** GE Medical Systems, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-02-03
- **Report date:** 2026-04-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waukesha, WI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1590-2026

## Citation

> AI Analytics. FDA recall Z-1590-2026. Retrieved 2026-07-29 from https://api.ai-analytics.org/recall/Z-1590-2026. Source: US FDA. Licensed CC0.

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