FDA Device recall Z-0994-2022
syngo.via RT Image Suite upgraded to VB60 running on syngo.via Model Number 10496180
- FDA Device
- Class II
- terminated
- Published 2022-05-04
On 2022-05-04 the FDA classified a Class II recall of syngo.via RT Image Suite upgraded to VB60 running on syngo.via Model Number 10496180 by Siemens Medical Solutions Usa, citing upgraded software version makes an automatic change in laser configuration settings for "markerless workflow" which may lead to the wrong laser offset coordinates being displayed….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0994-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-03-07 |
| Published | 2022-05-04 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
syngo.via RT Image Suite upgraded to VB60 running on syngo.via Model Number 10496180. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.
Reason
Upgraded software version makes an automatic change in laser configuration settings for "markerless workflow" which may lead to the wrong laser offset coordinates being displayed in the Patient Marking step.
Identifiers
| code_info | Serial Number 133527 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0994-2022%22
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