# FDA recall Z-3188-2018

> **EOS Imaging** · Class II · device recall initiated 2018-08-01.

## Product

sterEOS workstation

## Reason for recall

3D projections may be incorrect when  the pair of images used is a secondary capture generated from a series containing more than two images, where one of the images has been manually flipped.  Projection errors may lead to errors in calculation of 3D clinical parameters when  adjusting the position, size and shape of the 3D objects used.  Incorrect clinical parameters can be a contributing factor in incorrect clinical decisions, or sub-optimal surgical interventions.

## Distribution

US nationwide

## Key facts

- **Recall number:** Z-3188-2018
- **Recalling firm:** EOS Imaging
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-08-01
- **Report date:** 2018-09-26
- **Termination date:** 2022-08-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Paris, N/A, France

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3188-2018

## Citation

> AI Analytics. FDA recall Z-3188-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-3188-2018. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*