Achieva 3 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 Achieva 3.0T; Model Numbers (REF): (1) 781177, (2) 781277, (3) 781278, (4) 781344, (5) 781345;
- Recall number
- Z-2200-2025
- 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
Achieva 3.0T; Model Numbers (REF): (1) 781177, (2) 781277, (3) 781278, (4) 781344, (5) 781345;
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