Class II

Medical Device Recall: Product Name: Evolution Upgrade 1.5T; Model Numbers: (1) 782116, (2) 782148;

Philips North America Llc · May 13, 2025

Reason for Recall

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

Distribution

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.

States Affected

NATIONWIDE

Quantity Affected

52 units (3 US, 49 OUS)

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1793-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Philips North America Llc Medical Device Recall: Product Name: Evolution Upgrade 1.5T; Model Numbers: (1) 782116, (2) 782148; | SafeCheck