Class II — Potential Health Hazard

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

GE Healthcare Recalled by GE Healthcare, LLC Due to GE Healthcare has become aware that when analyzing...

Date: March 27, 2012
Company: GE Healthcare, LLC
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 GE Healthcare, LLC directly.

Affected Products

GE Healthcare, Advantage Workstation, READY View Application. Image analysis software.

Quantity: 318 (28 USm 290 OUS)

Why Was This Recalled?

GE Healthcare has become aware that when analyzing fMRI images using the READY View application software, incorrect fMRI activation maps may be computed and displayed.

Where Was This Sold?

This product was distributed to 5 states: IL, MN, NJ, NY, VA

Affected (5 states)Not affected

About GE Healthcare, LLC

GE Healthcare, LLC has 474 total recalls tracked by RecallDetector.

Related Recalls

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