Class II — Potential Health Hazard

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

Product Name: SmartPath to Ingenia Elition X Recalled by Philips North America Llc Due to Potential for alignment errors in the cross reference...

Date: May 13, 2025
Company: Philips North America 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 Philips North America Llc directly.

Affected Products

Product Name: SmartPath to Ingenia Elition X; Model Numbers: (1) 782118, (2) 782144;

Quantity: 16 units (All OUS)

Why Was This Recalled?

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Philips North America Llc

Philips North America Llc has 301 total recalls tracked by RecallDetector.

Related Recalls

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