Recall Z-0678-2025— Hermes Medical Solutions AB

Name: FDA recall Z-0678-2025
Creator: U.S. Food and Drug Administration
Published: 2024-10-31

Class II · Ongoing

Class II FDA medical device recall by Hermes Medical Solutions AB, initiated 2024-10-31. It names one FDA 510(k) clearance: K171681. 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: Due a potential software/configuration issue that may result is incorrect alignment during reconstructing a SPECT/CT study..

Recalling firm: Hermes Medical Solutions AB
Classification: Class II
Status: Ongoing
Initiated: 2024-10-31
Firm location: Stockholm, Sweden

510(k) clearances named in this recall

1 on FDA's record

K171681 — Hermes Medical Imaging Suite v5.7Hermes Medical Solutions AB·cleared 2017-11-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.