FDA Device recall Z-0678-2025
Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software versions affected are 4.0.0x and 5.0.0
- FDA Device
- Class II
- ongoing
- Published 2024-12-18
On 2024-12-18 the FDA classified a Class II recall of Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software versions affected are 4.0.0x and 5.0.0 by Hermes Medical Solutions Ab, citing due a potential software/configuration issue that may result is incorrect alignment during reconstructing a SPECT/CT study.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0678-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-10-31 |
| Published | 2024-12-18 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Hermes Medical Solutions Ab |
| Distribution | CA, CT, FL, HI, KY, MA, MD, MO, NJ, NY, OH, TN, TX, VA, WA |
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.
Identifiers
| code_info | Hermes Medical Imaging System version 6.1 with Hybrid Recon version 4.0.x UDI-DI code: 00859873006158 Serial Numbers: P…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0678-2025%22
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