Philips North America Llc recalls Product Name: SmartPath to Ingenia Elition X; Model Numbers: (1) 782118, (2) 782144;

Recall date

May 13, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1791-2025

FDA classification

Class II

Brand / firm

Philips North America Llc

Sold / distributed

Worldwide distribution - US Nationwide and the countries of Andorra, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, C¿te D'Ivoire, Cyprus, Czech Republic, Denmark, Finland, France, French Guiana, Georgia, Germany, Greece, Guadeloupe, Hong Kong, Iceland, Indonesia, Iran, Ir…

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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