Dec

2024

FDA Recall: Software Configuration Issue May Result in Incorrect Alignment

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 Medical Solutions AB

VOLUME OF PRODUCT IN COMMERCE:

778 systems

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

About the author

Allison Pate

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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FDA Recall: Software Configuration Issue May Result in Incorrect Alignment

Allison Pate

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