Z-1791-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 28, 2025
- Initiation Date
- May 13, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16 units (All OUS)
Product Description
Product Name: SmartPath to Ingenia Elition X; Model Numbers: (1) 782118, (2) 782144;
Reason for Recall
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
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.
Code Information
Model Numbers: (1) 782118, (2) 782144; UDI-DI: (1) 00884838099746, (2) 00884838108677; Serial Numbers: (1) 42072, 42194, 42306, 71019, 71025, 71050, 85661, 85676, (2) 42062, 42105, 42323, 42346, 42441, 71278, 71504, 71508;