Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software versions affected are 4.0.0x and 5.0.0
This recall is currently active, issued December 12, 2024. It was issued by Hermes Medical Solutions Ab Strandbergsgatan 16 Stockholm Sweden.
- Recall Initiated
- October 31, 2024
- Posted
- December 12, 2024
- Recall Number
- Z-0678-2025
- Quantity
- 778 systems
- Official Source
- View on FDA website ↗
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
Lot / Code Info
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
Root Cause
Device Design
Action Taken
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