Company: Hermes Medical Solutions AB
Date of Enforcement Report: 12/12/2024
Class II
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
Recall Number:
Z-0678-2025
REASON:
Due a potential software/configuration issue that may result is incorrect alignment during reconstructing a SPECT/CT study.
RECALLING FIRM/MANUFACTURER:
Hermes Medical Solutions AB
VOLUME OF PRODUCT IN COMMERCE:
778 systems
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
