Class II — Potential Health Hazard

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

Optima MR450w Recalled by GE Healthcare, LLC Due to An error on the SR Viewer Reporting Tool...

Date: May 10, 2011
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

Optima MR450w, Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant, and GE 1.5T Signa HDe MR System. The GE Signa HDx MR system is a whole body magnetic resonance scanner.

Quantity: 4026 (1672 US; 2354 OUS)

Why Was This Recalled?

An error on the SR Viewer Reporting Tool in which edits can be made on a report and can be saved into incorrect reports.

Where Was This Sold?

This product was distributed to 1 state: RI

Affected (1 state)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