# FDA recall Z-2167-2026

> **Hologic, Inc** · Class II · device recall initiated 2026-04-08.

## Product

SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D, SDM-SYS-6000-3D, SDM-00001-2D, SDM-00001-3D, SDM-00001-M2D, SDM-00001-M3D, SDM-05000-2A2, SDM-05000-2A3, SDM-05000-2AC, SDM-05000-2D2, SDM-05000-2D3, SDM-05000-2DC, SDM-05000-3D2, SDM-05000-3D3, SDM-05000-3DC, SDM-SYS-9000-2D, SDM-SYS-9000-3D.

## Reason for recall

Complaints have been received of systems developing loose, missing, or broken internal bolts over time.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-2167-2026
- **Recalling firm:** Hologic, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-04-08
- **Report date:** 2026-05-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Marlborough, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2167-2026

## Citation

> MORVS. FDA recall Z-2167-2026. Retrieved 2026-10-17 from https://api.morvs.ai/recall/Z-2167-2026. Source: US FDA. Licensed CC0.

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