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 CT systems with the SmartStep Option The system is Recalled by GE Healthcare, LLC Due to On the Revolution CT systems equipped with the...

Date: July 12, 2018
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 CT systems with the SmartStep Option The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.

Quantity: 131 units

Why Was This Recalled?

On the Revolution CT systems equipped with the SmartStep Option, the Z location displayed on image annotation and on the gantry display may not be the actual location of the table and result in the system scanning at a location that is not what was confirmed by the operator

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 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