FDA Device recall Z-2447-2021
MR MAGNETOM Systems with RT Image Suite with syngo MR VA20A, VA30A and VA31A with license SW-Key CT_RT_IMA_SUITE_SYNTHETIC_CT Material Numb…
- FDA Device
- Class II
- ongoing
- Published 2021-09-22
On 2021-09-22 the FDA classified a Class II recall of MR MAGNETOM Systems with RT Image Suite with syngo MR VA20A, VA30A and VA31A with license SW-Key CT_RT_IMA_SUITE_SYNTHETIC_CT Material Numb… by Siemens Medical Solutions Usa, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2447-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-08-16 |
| Published | 2021-09-22 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
MR MAGNETOM Systems with RT Image Suite with syngo MR VA20A, VA30A and VA31A with license SW-Key CT_RT_IMA_SUITE_SYNTHETIC_CT Material Numbers: 11060815
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).
Identifiers
| code_info | Serial Numbers: 176302 175681 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2447-2021%22
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