# FDA recall Z-3248-2024

> **Hologic Inc** · Class II · device recall initiated 2024-08-19.

## Product

Selenia Dimensions/ 3Dimensions-Digital breast tomosynthesis  Software Version Dimensions 1.12.0 and 3Dimensions 2.3.0 system software as follows  Model/Catalog Number:  1.	ASY-16824	FMI UPGRADE KIT, DIMENSIONS 1.12.0.3 SYSTEM SOFTWARE UPGRADE FOR 1.11.1 SYSTEMS  2.	ASY-16825	FMI UPGRADE KIT, 3DIMENSIONS 2.3.0.3 SYSTEM SOFTWARE UPGRADE FOR 2.2.1 SYSTEMS  3.	ASY-17219	FMI UPGRADE KIT, DIMENSIONS 1.12.0.3 SYSTEM SOFTWARE UPGRADE FOR 1.10.0 SYSTEMS  4.	ASY-17220	FMI UPGRADE KIT, 3DIMENSIONS 2.3.0.3 SYSTEM SOFTWARE UPGRADE FOR 2.1.0 SYSTEMS  5.	ASY-17221	FMI UPGRADE KIT, DIMENSIONS 1.12.0.3 SYSTEM SOFTWARE UPGRADE FOR 1.11.0 SYSTEMS  6.	ASY-17222	FMI UPGRADE KIT, 3DIMENSIONS 2.3.0.3 SYSTEM SOFTWARE UPGRADE FOR 2.2.0 SYSTEMS  7.	3DM-LIC-SW-UP-V2.3	DIMENSIONS SOFTWARE 2.3 (3DIMENSIONS)  8.	SDM-LIC-SW-UP-V1.12	DIMENSION SOFTWARE 1.12 (SELENIA DIMENSIONS)

## Reason for recall

Identified an issue with Selenia Dimensions 1.12.0 and 3Dimensions 2.3.0 system software when used in combination with C-View software in which the quality of the final C-View synthesized 2D image is impacted and may appear blurry and result in misdiagnosis with the possibility being a false negative diagnosis

## Distribution

Worldwide distribution - US Nationwide and the countries of Belgium, Canada, Israel, Korea, Republic of, Netherlands.

## Key facts

- **Recall number:** Z-3248-2024
- **Recalling firm:** Hologic Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-08-19
- **Report date:** 2024-10-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Newark, DE, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3248-2024

## Citation

> AI Analytics. FDA recall Z-3248-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-3248-2024. Source: US FDA. Licensed CC0.

---

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