Philips North America Llc: Device Recall

Recall #Z-1801-2025 · 05/13/2025

Class II: Risk

Recall Details

Recall Number
Z-1801-2025
Classification
Class II
Product Type
Device
Recalling Firm
Philips North America Llc
Status
Ongoing
Date Initiated
05/13/2025
Location
Cambridge, MA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
300 units (81 US, 219 OUS)

Reason for Recall

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

Product Description

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

Distribution Pattern

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.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.