High risk Medical DevicesClass II

GE Allia IGS 3 Pulse X-ray System Recall

Allia IGS 3 Pulse angiographic X-ray system

Updated April 20, 2026

An electrical cable defect in certain GE Allia IGS 3 Pulse angiographic X-ray systems equipped with Gaia generators poses a risk of electrical shock to service personnel during installation, maintenance, or troubleshooting when the system is powered on.

Is the GE Medical Systems, LLC recalled? Yes. This product was recalled by FDA on April 20, 2026. Details below.

What is recalled

GE HealthCare Allia IGS 3 Pulse angiographic X-ray systems equipped with Gaia generators.

Am I affected

You are affected if you are a service technician or personnel who installs, maintains, or troubleshoots GE Allia IGS 3 Pulse systems with Gaia generators, particularly when working inside the C-FRT cabinet with power on.

What to do right now

Contact GE HealthCare immediately if you service or maintain one of these systems. Do not open or work inside the C-FRT cabinet while the system is powered on until you have received guidance from the manufacturer.

The hazard

GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.

Brands affected

Source
FDA
Category
Medical Devices
Recall ID
fda-Z-2314-2026
Classification
Class II
Recalled
April 20, 2026
Read the official notice

Get free recall alerts

New Medical Devices recalls, the moment they post.

Free forever. Unsubscribe anytime. We never sell your data.

More Medical Devices recalls