# FDA recall Z-2972-2020

> **Imactis** · Class II · device recall initiated 2020-08-24.

## Product

Imactis Patient Fiducial  (Patient Referential), REF: IHR-YY-XXX component   used in conjunction with the ImactisCT-Navigation Workstation (REF J02000/J00180)

## Reason for recall

The firm has received reports concerning the patient fiducial disk separating from the body and users attempting  to re-assemble the device.  The use of a  re-assembled patient fiducial could lead to inability to navigate or inaccuracies such as improper needle trajectory.

## Distribution

US Nationwide distribution including in the states of FL & WI.

## Key facts

- **Recall number:** Z-2972-2020
- **Recalling firm:** Imactis
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-08-24
- **Report date:** 2020-09-23

- **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-2972-2020

## Citation

> AI Analytics. FDA recall Z-2972-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2972-2020. Source: US FDA. Licensed CC0.

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