Recall Z-0771-2021 ยท JAK System, X-Ray, Tomography, Computed
Siemens Medical Solutions USA, Inc
SOMATOM Force, Definition AS, Definition Edge, Definition Flash, Drive, Confidence and Edge Plus
| Date | Nov 24, 2020 |
| Status | Terminated |
| Reason | System does not trigger a cancel command followed by a reload of the scan with the new parameter(s). This issue may result in a delay in diagnosis and/or need for patient rescan |
| Root cause | Software design |
| Action | Customer notification letters will be sent starting December 14, 2020 to all affected customers via Customer Advisory Notice CT057/20/S. The technical solution, software versionVB20A_SP3, will be distributed to all affected customers free of charge via CT056/20/S. For questions or technical support, contact your local application specialists or your local service/sales organization at 1-800-888-7436. |
| Quantity | 3044 |
| Distribution | US 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 |
| K173607 | SOMATOM Edge Plus Siemens Medical Solutions USA, Inc., Mar 21, 2018 |