Home / Recalls / Hermes Medical Solutions AB / Z-0678-2025

Z-0678-2025 Class II Ongoing

Recalled by Hermes Medical Solutions AB — Stockholm

Recall Details

Product Type: Devices
Report Date: December 18, 2024
Initiation Date: October 31, 2024
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 778 systems

Product Description

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 Pattern

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

Code Information

Hermes Medical Imaging System version 6.1 with Hybrid Recon version 4.0.x UDI-DI code: 00859873006158 Serial Numbers: Pending Hybrid Recon version 5.0.0 UDI code: (01)00859873006196(8012)005000000 Serial Numbers: Pending