Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software versions affected are 4.0.0x and 5.0.0
Reported: December 18, 2024 Initiated: October 31, 2024 #Z-0678-2025
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.
Details
- Recalling Firm
- Hermes Medical Solutions AB
- Units Affected
- 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
- Location
- Stockholm
Frequently Asked Questions
What product was recalled? ▼
Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software versions affected are 4.0.0x and 5.0.0. Recalled by Hermes Medical Solutions AB. Units affected: 778 systems.
Why was this product recalled? ▼
Due a potential software/configuration issue that may result is incorrect alignment during reconstructing a SPECT/CT study.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 18, 2024. Severity: Moderate. Recall number: Z-0678-2025.
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