Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Hologic 3Dimensions/Selenia Dimensions Models: RM-SDM-00001-3D SDM-00001-2D SDM-00001-3D SDM-05000-3D3 SDM-05000-2DC SDM-00001-M3D Recalled by Hologic, Inc. Due to C-Arm unexpected movement may cause blunt trauma should...

Date: January 16, 2023
Company: Hologic, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Hologic, Inc. directly.

Affected Products

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

Quantity: 797 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Hologic, Inc.

Hologic, Inc. has 18 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report