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Philips North America Llc recalls Product Name: Ingenia Elition X; Model Numbers: (1) 781358, (2) 782107, (3) 782136;

Recalled May 28, 2025 · FDA recall Z-1803-2025 · Philips North America

Hazard
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. · FDA Class II
Units
198 units (25 US, 173 OUS)
Sold at
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, Ireland, Israel, Italy, Japan, Jordan, Kenya, Latvia, Lebanon, Libya, Lithuania, Malaysia, Malta, Martinique, Mexico, Moldova, Monaco, Netherlands, New Zealand, Norway, Palestine, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Serbia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, U.A.E.

Description

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

Product
Product Name: Ingenia Elition X; Model Numbers: (1) 781358, (2) 782107, (3) 782136;
Manufacturer(s)
Philips North America Llc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Philips North America Llc recalls Product Name: Ingenia Elition X; Model Numbers: (1) 781358, (2) 782107, (3) 782136; | RecallWatchUSA