Device product
Upgrade to MR 7700. Product Code (REF): 782130. MR systems with SW version R11.1 and R12.1.
Z-1214-2026
Product summary
- Event
- Event 98111
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 6 units
- Official record key
device-enforcement:Z-1214-2026
Official wording
Reason: The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Code information: MR systems with SW version R11.1 and R12.1. Product Code (REF): 782130. UDI-DI: 00884838104402. Serial Numbers: 42030, 85644, 42163, 42151, 45236, 85643.
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.
Derived failure modes
-
Unknown
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).