Recall Z-2445-2021 ยท MUJ System, Planning, Radiation Therapy Treatment
Siemens Medical Solutions USA, Inc
syngo.via RT Image Suite with syngo.via VB30, VB40, VB50 and VB60- Intended for Radiation Therapy Treatment Material Number: 10496180
| 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 | 126 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K211379 | syngo.via RT Image Suite Siemens Medical Solutions USA, Inc., Jul 30, 2021 |