Recall Z-2446-2021 ยท JAK System, X-Ray, Tomography, Computed
Siemens Medical Solutions USA, Inc
syngo.CT VA20A, VA30A and VA40A in: syngo.via RT Image Suite / Sim&Go SOMATOM go.Now SOMATOM go.Up SOMATOM go.All SOMATOM go.Top SOMATOM go.Sim SOMATOM go.Open Pro and SOMATOM X.cite Material Numbers: 11061620 11061628 11061630 11061640 11061660 11061670
| Date | Sep 10, 2021 (initiated Aug 16, 2021) |
| Status | Open, Classified |
| Reason | Potential for data loss when using the contouring or patient marking workflow when editing a structure set after saving and reopening a study, resulting in an incomplete structure set sent to the treatment planning system (TPS). |
| Root cause | Software design |
| Action | Siemens has initiated three (3) Customer Safety Advisory Notices (CSANs) to affected customers via SY052/21/S, CT042/21/S and MR019/21/S by email or hand delivery by the Siemens Customer Service Engineer on 8/16/21. Temporary workarounds are available for some of the software versions and are described in the CSANs. Additionally, a solution to eliminate the root cause of this problem is being distributed via SY051/21/S (for SY and CT) and MR021/21/S for MR to all affected customers free of charge. The service organization will contact you to arrange a date to perform this corrective action f |
| Quantity | 44 systems |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K200524 | SOMATOM X.cite, Scan&GO, SOMATOM go.Platform - go.Up, go.Now, go.Top, go.All, go. Sim, go. Open Pro, Scan&GO Siemens Medical Solutions USA, Inc., Apr 1, 2020 |