Hermes Medical Solutions AB recalls Hybrid Recon software on Hermes Medical Imaging Suite versio
Recalled 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
Hazard / Issue
Due a potential software/configuration issue that may result is incorrect alignment during reconstructing a SPECT/CT study.
Issued by
FDA
Affected States: CA, CT, FL, HI, KY, MA, MD, MO, NJ, NY, OH, TN, TX, VA, WA
Lot/Code Info: 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
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