Hermes Medical Solutions AB recalls Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software versions affected are 4.0.0x an…
- Recall date
- October 31, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0678-2025
- FDA classification
- Class II
- Brand / firm
- Hermes Medical Solutions AB
- Sold / distributed
- 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
Why it was recalled
Due a potential software/configuration issue that may result is incorrect alignment during reconstructing a SPECT/CT study.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software versions affected are 4.0.0x and 5.0.0
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