# FDA recall Z-1144-2023

> **Hologic, Inc.** · Class II · device recall initiated 2023-01-16.

## Product

Hologic 3Dimensions/Selenia Dimensions   Models:  RM-SDM-00001-3D  SDM-00001-2D  SDM-00001-3D  SDM-05000-3D3  SDM-05000-2DC  SDM-00001-M3D  SDM-05000-3DC  SDM-SYS-6000-3D  SDM-05000-2D3  SDA-SYS-3000-2D  SDM-00001  SDM-SYS-9000-2D  SDM-00001-M2D  3DM-SYS-STD  3DM-SYS-STD-NS  SDM-05000-2AC  SDM-05000-2A2  SDA-SYS-3000-3D  SDA-SYS-3000-3D-UPS  SDM-SYS-6000-3D-HTC  SDM-05000-2D2  SDM-05000-3D2  SDM-SYS-6000-2D  SDM-SYS-9000-3D

## Reason for recall

C-Arm unexpected movement may cause blunt trauma  should the tube arm impinge upon an individual

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1144-2023
- **Recalling firm:** Hologic, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-01-16
- **Report date:** 2023-03-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Danbury, CT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1144-2023

## Citation

> AI Analytics. FDA recall Z-1144-2023. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-1144-2023. Source: US FDA. Licensed CC0.

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