Hermes Medical Solutions AB: Medical Device Recall in 2024 - (Recall #: Z-0678-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: October 31, 2024

Date Posted: December 18, 2024

Recall Number: Z-0678-2025

Event ID: 95673

Reason for Recall:

Due a potential software/configuration issue that may result is incorrect alignment during reconstructing a SPECT/CT study.

Status: Ongoing

Product Quantity: 778 systems

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

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

Voluntary or Mandated:

Voluntary: Firm initiated