Z-0678-2025 Class II Ongoing
FDA device recall Z-0678-2025 was initiated by Hermes Medical Solutions AB on October 31, 2024 and is designated Class II. Reason for recall: Due a potential software/configuration issue that may result is incorrect alignment during reconstructing a SPECT/CT study. The recall status is ongoing. Affected quantity: 778 systems.
Recall Details
- Product Type
- Devices
- Report Date
- December 18, 2024
- Initiation Date
- October 31, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 778 systems
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.
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
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