Class II — Potential Health Hazard

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

Ingenia Elition S Magnetic Resonance (MR) system Recalled by Philips North America Due to During installation of the SmokeDetector Interlock, a connecting...

Date: June 12, 2023
Company: Philips North America
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 Philips North America directly.

Affected Products

Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106

Quantity: 601 Total

Why Was This Recalled?

During installation of the SmokeDetector Interlock, a connecting cable, between the SmokeDetector Interlock and the host PC, may not have been properly installed. This connection is used for service diagnostics and does not impact the functionality of the system and/or the SmokeDetector Interlock system.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Philips North America

Philips North America has 107 total recalls tracked by RecallDetector.

Related Recalls

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