Z-1206-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- February 4, 2026
- Initiation Date
- December 3, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10 units
Product Description
Ingenia 1.5T. Product Code (REF): (1) 781341, (2) 781396. MR systems with SW version R11.1 and R12.1.
Reason for Recall
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Distribution Pattern
Worldwide - US Nationwide distribution in the states of AZ, CA, CO, IL, MA, ME, MI, MN, MS, NE, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA and the countries of Belgium, Canada, Denmark, France, Germany, Greece, India, Israel, Japan, Kenya, Netherlands, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom.
Code Information
MR systems with SW version R11.1 and R12.1. (1) Product Code (REF): 781341; UDI-DI: 00884838055322; Serial Numbers: 70311, 84560, 84403, 84467, 84462, 70042, 84433. (2) Product Code (REF): 781396; UDI-DI: 00884838009820; Serial Numbers: 41356, 41354, 41370.