Class II

Medical Device Recall: Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software versions affected are 4.0.0x and 5.0.0

Hermes Medical Solutions AB · October 31, 2024

Reason for Recall

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

Distribution

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

States Affected

CA, CT, FL, HI, KY, MA, MD, MO, NJ, NY, OH, TN, TX, VA, WA

Quantity Affected

778 systems

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0678-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Hermes Medical Solutions AB Medical Device Recall: Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software versions affected are 4.0.0x and 5.0.0 | SafeCheck