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 SIGNA Creator Recalled by GE Healthcare, LLC Due to GE Healthcare is conducting a recall dealing with...

Date: August 31, 2016
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 SIGNA Creator, SIGNA Explorer. Diagnostic Imaging Device.

Quantity: 383 (US = 24;OUS = 359)

Why Was This Recalled?

GE Healthcare is conducting a recall dealing with an incorrect RF Power Monitor Function involving SIGNA CREATOR and SIGNA EXPLORER which could result in higher than expected thermal dose to the patient and higher than expected localized heating. There have been no failures of this type reported, and no injuries reported as a result of this issue.

Where Was This Sold?

This product was distributed to 11 states: AZ, CA, CT, FL, IL, MA, MS, MO, NC, TX, WI

Affected (11 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