FDAFDA · Food and drugs·Recall number Z-0678-2025
Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software versions affected are 4.0.0x and 5.0.0
Published December 18, 2024 · Recall initiated: October 31, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Due a potential software/configuration issue that may result is incorrect alignment during reconstructing a SPECT/CT study.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Hermes Medical Solutions AB
- Distributor
- 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
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Sweden
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