Recall Z-0475-2022 ยท JAK System, X-Ray, Tomography, Computed
Siemens Medical Solutions USA, Inc
SOMATOM Definition Edge -Computed tomography system Model 10590000
| Date | Nov 19, 2021 |
| Status | Open, Classified |
| Reason | Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis. |
| Root cause | Software Design Change |
| Action | Siemens issued Urgent Medical Device Correction letter CSAN CT067/21/S on November 19, 2021, to notify affected customers of the head image degradation issue and to provide them with a workaround solution. Letter states reason for recall, health risk and action to take: To avoid potential misdiagnosis, it is mandatory to change to the new cupping correction setting CC = 4 immediately, restart the application, and (if applicable) reconstruct the raw data again. Cupping correction setting CC = 4 is a further development of CC = 1: The Image impression is very similar to setting CC = 1 but an imp |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190578 | SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Edg Siemens Medical Solutions USA, Inc., Jun 27, 2019 |