# FDA recall Z-0678-2025

> **Hermes Medical Solutions AB** · Class II · device recall initiated 2024-10-31.

## 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 for recall

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

## Key facts

- **Recall number:** Z-0678-2025
- **Recalling firm:** Hermes Medical Solutions AB
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-10-31
- **Report date:** 2024-12-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Stockholm, Sweden

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0678-2025

## Citation

> AI Analytics. FDA recall Z-0678-2025. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0678-2025. Source: US FDA. Licensed CC0.

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