Stockholm, Sweden
Hermes Medical Solutions AB recalls
1 recall recorded since 2018, most recently on 31 October 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 31 October 2024
- Reason
- Due a potential software/configuration issue that may result is incorrect alignment during reconstructing a SPECT/CT study.
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.