FDA Device recall Z-2446-2021
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…
- FDA Device
- Class II
- ongoing
- Published 2021-09-22
On 2021-09-22 the FDA classified a Class II recall of 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… 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-2446-2021 |
| 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
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
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: 128051 130051 128065 128035 130057 128086 128079 128041 128019 128078 128060 128068 112045 128085 12807…Serial Numbers: 128051 130051 128065 128035 130057 128086 128079 128041 128019 128078 128060 128068 112045 128085 128075 128022 128033 130012 128016 130044 130048 130049 128018 119216 108085 128015 130019 130055 130054 128020 128039 130052 130036 130061 128049 117756 128029 130021 130045 130039 128063 128057 128045 128046 ***UPDATED 12/9/21*** 128114 128113 130058 ***Updated 1/31/22: Serial Number 128123 130015 130081 112261 112071 128124 128132 128125 130079 130077 Expanded Recall 3/12/22: 11061620 S/N: 111805 11061660 S/N: 128144, 128135, 128142, 128136, 128133 11061670 S/N: 130088, 130094, 130090, 130087, 130091, 130092, 130089 |
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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-2446-2021%22
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