Hermes Medical Solutions AB: Device Recall
Recall #Z-0678-2025 · 10/31/2024
Class II: Risk
Recall Details
- Recall Number
- Z-0678-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Hermes Medical Solutions AB
- Status
- Ongoing
- Date Initiated
- 10/31/2024
- Location
- Stockholm, Sweden
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 778 systems
Reason for Recall
Due a potential software/configuration issue that may result is incorrect alignment during reconstructing a SPECT/CT study.
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
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
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.