# FDA recall Z-2297-2025

> **PIE Medical Imaging B.V.** · Class II · device recall initiated 2025-07-14.

## Product

3mensio Workstation (Vascular Fenestrated) software

## Reason for recall

When fenestrated analysis with clock measurements is started in diagnostic bioimaging software (intended to measure/visualize cardiovascular structures) and the 12h position of a single clock is changed, other clock measurements are not updated relative to the new 12h position which may cause stent graft fenestrations at incorrect position, which may lead to blood flow disruption and tissue damage

## Distribution

US Nationwide distribution in the states of MN, NJ, GA, NY, OH, KS, MA, CA, TX, MS, NE, NC.

## Key facts

- **Recall number:** Z-2297-2025
- **Recalling firm:** PIE Medical Imaging B.V.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-07-14
- **Report date:** 2025-08-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Maastricht, N/A, Netherlands

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2297-2025

## Citation

> AI Analytics. FDA recall Z-2297-2025. Retrieved 2026-07-06 from https://api.ai-analytics.org/recall/Z-2297-2025. Source: US FDA. Licensed CC0.

---

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