Hermes Medical Solutions AB Strandbergsgatan 16 Stockholm Sweden Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software versions affected are 4.0.0x and 5.0.0 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Hermes Medical Solutions AB Strandbergsgatan 16 Stockholm Sweden
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
Hermes Medical Solutions AB Strandbergsgatan 16 Stockholm Sweden is recalling Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software versions aff due to Due a potential software/configuration issue that may result is incorrect alignment during reconstructing a SPECT/CT study.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due a potential software/configuration issue that may result is incorrect alignment during reconstructing a SPECT/CT study.
Recommended Action
Per FDA guidance
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: support@hermesmedical.com Canada: support.ca@hermesmedical.com USA: support.us@hermesmedical.com
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, CT, FL, HI, KY, MD, MA, MO, NJ, NY, OH, TN, TX, VA, WA
Page updated: Jan 10, 2026