FDA recall Z-0678-2025

Hermes Medical Solutions AB · Class II · device

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

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

Key facts

Status
Ongoing
Initiation date
2024-10-31
Report date
2024-12-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Stockholm, Sweden

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0678-2025