Medical Device Recall: Product Name: Ingenia Ambition S; Model Numbers: (1) 781359, (2) 782108, (3) 782139;
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
152 units (25 US, 127 OUS)
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1798-2025
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.