Hybrid Recon software on Hermes Medical Imaging Suite version 6 — Class II medical device recall Z-0678-2025
Ongoing recall by Hermes Medical Solutions AB, reported 2024-12-18, distributed in CA, CT, FL, HI, KY, MA, MD, MO…. Due a potential software/configuration issue that may result is incorrect alignment during reconstructing a SP
| Recall number | Z-0678-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hermes Medical Solutions AB, Stockholm, Sweden |
| Recall initiated | 2024-10-31 |
| Classified | 2024-12-12 |
| Reported by FDA | 2024-12-18 |
| Distributed | CA, CT, FL, HI, KY, MA, MD, MO, NJ, NY, OH, TN, TX, VA, WA |
| Countries outside the US | DE |
| Quantity | 778 systems |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00859873006158, 00859873006196 |
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
Reason for recall
Due a potential software/configuration issue that may result is incorrect alignment during reconstructing a SPECT/CT study.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0678-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.