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 Fluoroscan Mini C-Arm Model with InSight- FD Software Version Recalled by Hologic, Inc. Due to Fluoroscan Mini C-Arm models -InSight2, version 4.0 and...

Date: September 14, 2012
Company: Hologic, Inc.
Status: Terminated
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 Fluoroscan Mini C-Arm Model with InSight- FD Software Version 5.0.1and 5.0.2 The device is a Mini C-arm Fluoroscopic Imaging System designed to provide -physicians with general fluoroscopic visualization of a patient, including but not limited to surgical orthopedic and podiatry use, critical and emergency procedures, and light anatomy imaging situation.

Quantity: 46 units

Why Was This Recalled?

Fluoroscan Mini C-Arm models -InSight2, version 4.0 and 4.0.1 - DICOM images stored in PACS may be flipped 180¿around vertical axis. InSight FD, version 5.0.1 and 5.0.2 - DICOM images stored in PACS may be lipped 180¿ around vertical axis as well as 180¿ around a horizontal axis.

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