# FDA recall Z-1264-2021

> **Imactis** · Class II · device recall initiated 2021-02-11.

## Product

Impactis NaviKit-stereotaxic accessory for Computed Tomography systems    Reference # I10100

## Reason for recall

Defect in the mechanical assembly of the needle holder contained in the navigation kit. One of the 2 jaws of the needle holder does not provide gripping functionality; if the defect is not detected before use, it can cause poor needle guidance and a lack of precision during navigation causing an inaccurate needle position which could cause damage to organs or vasculature adjacent to the trajectory

## Distribution

NJ, NY, WI

## Key facts

- **Recall number:** Z-1264-2021
- **Recalling firm:** Imactis
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-02-11
- **Report date:** 2021-03-24
- **Termination date:** 2023-10-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** St Martin D Heres, N/A, France

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1264-2021

## Citation

> AI Analytics. FDA recall Z-1264-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1264-2021. Source: US FDA. Licensed CC0.

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