Class II — Hermes Medical Solutions AB
| Recalling firm | HERMES MEDICAL SOLUTIONS AB |
|---|---|
| Registered facility | HERMES MEDICAL SOLUTIONS, AB (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Due a potential software/configuration issue that may result is incorrect alignment during reconstructing a SPECT/CT study. |
| 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 |
| Quantity | 778 systems |
| Distribution | 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 |
| Initiated | 2024-10-31 |
| Classified | 2024-12-12 |
| Recall number | Z-0678-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Hermes Medical Solutions AB (Z-0678-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95673/
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