Recall Z-2440-2019 ยท JAK System, X-Ray, Tomography, Computed
Siemens Medical Solutions USA, Inc
syngo.CT software version VA48A_SP5.5 in the following SOMATOM computed tomography models: SOMATOM Definition Edge-Model #10590000; SOMATOM Definition AS Model #8098027; SOMATOM Definition Flash Model #10430603
| Date | Jul 25, 2019 |
| Status | Terminated |
| Reason | SOMATOM Definition Edge, SOMATOM Definition AS, SOMATOM Definition Flash with software syngo.CT with Software version VA48A_SP5 may result in scanning workflow interruptions and unexpected user notifications. and may result in a delay in diagnosis and/or patient rescans |
| Root cause | Software design |
| Action | Siemens issued notification Urgent Medical Device Correction letter on 7/25/19 issued via electronic mail to consignees or by USPS certified mail if a consignee email address was not available. Letter states problem, health risk, action to take: The remote software update installation process will require approximately 30 minutes for completion. The process is completely automatic; make sure the system and power are stable before and during the process and do not switch off the system during the update process. Siemens highly recommends starting the installation when the scanner will not be in |
| Quantity | 2867 units worldwide (OUS); 1464 units US |
| Distribution | Nationwide Foreign: |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143400 | SOMATOM Definition AS/AS+ Siemens Medical Solutions USA, Inc., Apr 8, 2015 |
| K143401 | SOMATOM Definition Edge Siemens Medical Solutions USA, Inc., Apr 6, 2015 |
| 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 |