Day

December 12, 2024
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...
Read More

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.