Software: Syngo — Class II medical device recall Z-3005-2020
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2020-09-30, distributed nationwide. Calibration offset between the central CT image plane and the external RT lasers has been set automatically to
| Recall number | Z-3005-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2020-08-19 |
| Classified | 2020-09-23 |
| Reported by FDA | 2020-09-30 |
| Terminated | 2023-04-19 |
| Distributed | Nationwide (US) |
| Quantity | 64 systems |
| 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 and 39 more |
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 for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3005-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.