FDA Device recall Z-3005-2020
Software: Syngo.via RT Image Suite software version VA30_SP02 with license T_RT_IMAGE_SUITE_PAT_MARK Intended Use: used as an advanced appl…
- FDA Device
- Class II
- terminated
- Published 2020-09-30
On 2020-09-30 the FDA classified a Class II recall of Software: Syngo.via RT Image Suite software version VA30_SP02 with license T_RT_IMAGE_SUITE_PAT_MARK Intended Use: used as an advanced appl… by Siemens Medical Solutions Usa, citing calibration offset between the central CT image plane and the external RT lasers has been set automatically to the factory default of 50.00 cm, if the misadjustment of the offset….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3005-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-08-19 |
| Published | 2020-09-30 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
Software: Syngo.via RT Image Suite software version VA30_SP02 with license T_RT_IMAGE_SUITE_PAT_MARK Intended Use: used as an advanced application on a SOM10 scanner SMN: 10496180
Reason
Calibration offset between the central CT image plane and the external RT lasers has been set automatically to the factory default of 50.00 cm, if the misadjustment of the offset value is not recognized during the subsequent treatment planning process or remains undetected during the position verification at the treatment system (e.g. linear accelerator), this can potentially result in an incorrect dose or dose applied to the wrong location
Identifiers
| code_info | Serial Numbers: 100418 100419 100420 100421 100641 100642 100643 100644 100645 100704 100713 100735 10081…Serial Numbers: 100418 100419 100420 100421 100641 100642 100643 100644 100645 100704 100713 100735 100811 100812 100813 100814 101724 102013 102031 102108 102305 102369 130125 130140 130331 130335 130628 130751 130848 130874 131012 131169 131247 131284 131325 131336 131360 131503 131578 131589 131801 131966 132011 132061 132102 132108 132136 132231 132595 132729 222224 222411 222417 222475 222491 222539 222563 222601 222638 222686 222946 223004 223084 451001 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3005-2020%22
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