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.