Hybrid Recon software on Hermes Medical Imaging Suite… recallZ-0678-2025 · Hermes Medical Solutions AB · initiated Oct 31, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Hermes Medical Solutions AB or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Due a potential software/configuration issue that may result is incorrect alignment during reconstructing a SPECT/CT study.
FDA root cause category: Device Design
What the company is doing
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]
Recall details
- Recall number
- Z-0678-2025
- Status
- Open, Classified
- Initiated by the company
- Oct 31, 2024
- Posted by the FDA
- Dec 12, 2024
- Recalling firm
- Hermes Medical Solutions AB
- Quantity
- 778 systems
- Product code
- KPS
- FDA submissions
- K171681
- 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 description
Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software versions affected are 4.0.0x and 5.0.0
Code information (models, lots, serial numbers)
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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Hermes Medical Imaging Suite 00859873006158Hermes Medical Solutions AB · System, Tomography, Computed, Emission1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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