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Recall Observatory FDA recall evidence

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

October 31, 2024

Class II

Product summary

Firm
Hermes Medical Solutions AB
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

    reason.device_software_design · v1.0.0

    software/configuration issue that may result is incorrect