Device product
Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software versions affected are 4.0.0x and 5.0.0
Z-0678-2025
Product summary
- Event
- Event 95673
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 778 systems
- Official record key
device-enforcement:Z-0678-2025
Official wording
Reason: Due a potential software/configuration issue that may result is incorrect alignment during reconstructing a SPECT/CT study.
Code information: Hermes Medical Imaging System version 6.1 with Hybrid Recon version 4.0.x UDI-DI code: 00859873006158 Serial Numbers: Pending Hybrid Recon version 5.0.0 UDI code: (01)00859873006196(8012)005000000 Serial Numbers: Pending
Distribution pattern: U.S.: CA, CT, FL, HI, KY, MA, MD, MO, NJ. NY, OH, TN, TX, VA, and WA O.U.S.: Germany, and United Kingdoms
Derived failure modes
-
Device software or design
software/configuration issue that may result is incorrect