Recall Z-0678-2025 ยท KPS System, Tomography, Computed, Emission
Hermes Medical Solutions AB
Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software versions affected are 4.0.0x and 5.0.0
| Date | Dec 12, 2024 (initiated Oct 31, 2024) |
| Status | Open, Classified |
| Reason | Due a potential software/configuration issue that may result is incorrect alignment during reconstructing a SPECT/CT study. |
| 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 |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171681 | Hermes Medical Imaging Suite v5.7 Hermes Medical Solutions AB, Nov 21, 2017 |