Device product
Product Name: Ingenia 1.5T S; Model Number: 781347;
Z-1796-2025
Product summary
- Event
- Event 96889
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2 units (US Only)
- Official record key
device-enforcement:Z-1796-2025
Official wording
Reason: Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Code information: Model Number: 781347; UDI-DI: 00884838068421; Serial Numbers: 81042, 81072;
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.
Derived failure modes
-
Unknown
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.