---
title: "Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Reco... — FDA record Z-0678-2025 | Is It on Recall"
description: "Due a potential software/configuration issue that may result is incorrect alignment during reconstructing a SPECT/CT study."
url: https://isitonrecall.com/recall/fda-device-z-0678-2025-hybrid-recon-software-on-hermes-medical-imaging-suite-version-6-1-hybrid-recon-software-versions-aff/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software versions affected are 4.0.0x ... — FDA record Z-0678-2025

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Oct 31, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **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.
- **Classification**: Class II
- **Recalling firm**: Hermes Medical Solutions AB
- **Quantity**: 778 systems
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0678-2025

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0678-2025%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | 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 |

Match all identifying details in the current notice. A brand name alone is not enough.

## 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

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [California](https://isitonrecall.com/state/california/)
- [Connecticut](https://isitonrecall.com/state/connecticut/)
- [Florida](https://isitonrecall.com/state/florida/)
- [Hawaii](https://isitonrecall.com/state/hawaii/)
- [Kentucky](https://isitonrecall.com/state/kentucky/)
- [Massachusetts](https://isitonrecall.com/state/massachusetts/)
- [Maryland](https://isitonrecall.com/state/maryland/)
- [Missouri](https://isitonrecall.com/state/missouri/)
- [New Jersey](https://isitonrecall.com/state/new-jersey/)
- [New York](https://isitonrecall.com/state/new-york/)
- [Ohio](https://isitonrecall.com/state/ohio/)
- [Tennessee](https://isitonrecall.com/state/tennessee/)
- [Texas](https://isitonrecall.com/state/texas/)
- [Virginia](https://isitonrecall.com/state/virginia/)
- [Washington](https://isitonrecall.com/state/washington/)

## Dates in the source

- **Report date**: Dec 18, 2024
- **Recall initiation date**: Oct 31, 2024
- **Center classification date**: Dec 12, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0678-2025%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Hermes Medical Solutions AB records](https://isitonrecall.com/brand/hermes-medical-solutions-ab/)