Class II — Potential Health Hazard

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

Revolution EVO Recalled by GE Healthcare, LLC Due to Improperly loaded software options may result in additional...

Date: June 14, 2021
Company: GE Healthcare, LLC
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 GE Healthcare, LLC directly.

Affected Products

Revolution EVO, Optima CT660, Optima CT680 CT Systems.

Quantity: 3665

Why Was This Recalled?

Improperly loaded software options may result in additional X -ray radiation exposure to the patient.

Where Was This Sold?

3,665 (US = 956; OUS = 2,709)

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