Z-0678-2025Class II

Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software versions affected are...

Name: Z-0678-2025 Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software versions affected are...
Creator: Hermes Medical Solutions AB
Published: 2024-10-31
License: https://open.fda.gov/license/

Hermes Medical Solutions AB / initiated 2024-10-31 / Open, Classified / root cause: design

FDA source

Hermes Medical Solutions AB began a 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 on 2024-10-31. FDA classified it as Class II and gives the reason as "Due a potential software/configuration issue that may result is incorrect alignment during reconstructing a SPECT/CT study". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0678-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-10-31
Posted: 2024-12-12
Recalling firm: Hermes Medical Solutions AB
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
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: Due a potential software/configuration issue that may result is incorrect alignment during reconstructing a SPECT/CT study.
Root cause tag: design
FDA root cause: Device Design
Action: On 10/31/2024, the firm emailed a "Field Safety Notice (FSN)" letter to customers informing them that when reconstructing a SPECT/CT study, in some cases, the SPECT and CT series are not correctly aligned. This may be due to separately performed acquisitions, or due to the camera operator re-setting the reference point (landmark) between SPECT and CT acquisitions. Normally, the Hybrid Recon application warns the user if the Frames of Reference do not match, however in some configurations this warning message may be turned off. Customers are instructed how to avoid the problem by: In all cases, the user must verify correct SPECT to CT alignment by careful inspection of the fused images during reconstruction. To ensure that you are warned about possible SPECT to CT misalignment, the Skip Frame of Reference warning radio button shall not be set on . The Skip Frame of Reference warning radio button can be found in the Program Parameters window (button at top right corner of the window left side of the ? symbol). Go to the Recon tab and find the Skip frame of reference warning radio button. If the button is on as shown here, this warning will not be shown to the users. The setting of the Skip Frame of Reference warning radio button should be checked to ensure it is off for each workflow Oncology, Neurology, Cardiology and Lung. Please contact your Hermes Medical Solutions support if you do not have permission to make the changes required. For questions or further assistance contact General: [email protected] Canada: [email protected] USA: [email protected]
Quantity in commerce: 778 systems
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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0678-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0678-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-18	2024-12-12

Product code KPS

K171681Class IIHermes Medical Imaging Suite v5.7Hermes Medical Solutions AB / cleared 2017-11-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)