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

Recalled December 18, 2024 · FDA recall Z-0678-2025 · Hermes Medical Solutions AB

Hazard

Due a potential software/configuration issue that may result is incorrect alignment during reconstructing a SPECT/CT study. · FDA Class II

Units

778 systems

Sold at

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

Description

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

Manufacturer(s)

Hermes Medical Solutions AB

Made in

Sweden

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →