Recall Z-3025-2020 ยท JAK System, X-Ray, Tomography, Computed
Siemens Medical Solutions USA, Inc
Software versions syngo.CT VB20 or VB20_SP1 in the following systems: SOMATOM Force (Model #10742326) SOMATOM Definition As (Model #8098027) SOMATOM Definition Edge (Model #10590000) SOMATOM Definition Flash (Model #10430603) SOMATOM Drive (Model #10431700) SOMATOM Confidence (Model #10590100) SOMATOM Edge Plus (Model #10267000)
| Date | Sep 28, 2020 (initiated Jun 22, 2020) |
| Status | Terminated |
| Reason | Sporadic problems with the current software may result in scanning workflow interruptions and unexpected user notifications causing delay in diagnosis or patient rescan |
| Root cause | Software design |
| Action | Siemens Medical Solutions USA, Inc. has initiated a Customer Information Letter (CIL) to affected customers via CT004/20/S. The letter alerts customers of the technical issues and under what circumstances they may occur and health risk These issues will be resolved with software update version syngo CT VB20_SP2 (Service Pack 2) via UI CT003/20/S. The software update is being made available to all affected customers free of charge. If your system is connected to Siemens Remote Connection, this update will be performed remotely. The remote software update process will require approximately 2 ho |
| Quantity | 767 distributed in U.S. |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103127 | SOMATOM DEFINITION AS Siemens Medical Solutions USA, Inc., Mar 4, 2011 |
| K121072 | SOMATOM DEFINITION FLASH Siemens Medical Systems, Inc., May 8, 2012 |
| K133589 | SOMATOM FORCE Siemens Medical Solutions USA, Inc., Apr 17, 2014 |
| K142955 | SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, Siemens Medical Solutions USA, Inc., Nov 24, 2015 |
| K161196 | SOMATOM Drive Siemens Medical Solutions USA, Inc., Aug 24, 2016 |
| K173630 | SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Dei Siemens Medical Solutions USA, Inc., Mar 30, 2018 |