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 Innova IGS 630. Angiographic X-ray systems used in Recalled by GE Healthcare Due to GE Healthcare has recently become aware of a...

Date: May 29, 2015
Company: GE Healthcare
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 directly.

Affected Products

GE Healthcare Innova IGS 630. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.

Quantity: 8

Why Was This Recalled?

GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery).

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About GE Healthcare

GE Healthcare has 88 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report