Medical device recalls Moderate risk

Ingenia Ambition X recalled over fire hazard

Recall date
June 30, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Philips North America recalls Ingenia Ambition X Model Numbers (REF): (1) 781356, (2) 782109, (3) 782138;
Recall number
Z-2209-2025
FDA classification
Class II
Brand / firm
Philips North America
Sold / distributed
Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Belize, Bolivia, Bosnia-Herz., Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, C…

Why it was recalled

The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.

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

What was recalled

Ingenia Ambition X Model Numbers (REF): (1) 781356, (2) 782109, (3) 782138;

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