FDA-Device2024-12-18Class II
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
Hazard
Due a potential software/configuration issue that may result is incorrect alignment during reconstructing a SPECT/CT study.
Sold states
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
Affected count
778 systems
Manufactured in
Strandbergsgatan 16, Stockholm, Sweden
Products
Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software versions affected are 4.0.0x and 5.0.0
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0678-2025Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief