Software : myNeedle Guide 2D license — Class II medical device recall Z-1003-2023
Ongoing recall by Siemens Medical Solutions USA, Inc, reported 2023-02-01, distributed nationwide. In the syngo.CT VA40 and syngo.CT VA50 myNeedle Guide application, the order of the orientation labels head ,
| Recall number | Z-1003-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2022-12-22 |
| Classified | 2023-01-20 |
| Reported by FDA | 2023-02-01 |
| Distributed | Nationwide (US) |
| Quantity | 29 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 04056869051314, 04056869151564, 04056869151571, 04056869231044, 04056869231051, 04056869249247, 04056869263168 |
| Serial numbers | 112285, 112443, 117977, 117982, 119197, 123059, 123206, 123222, 123225, 123233, 123236, 123261, 123273, 123281, 123306, 123310, 123327, 123329, 125051, 125067, 127089, 130121, 172649, 172758, 172820 and 4 more |
| Model numbers | 11061610, 11061618, 11061620, 11061628, 11061630, 11061638, 11061640, 11061648, 11061660, 11061670, 11330001, 11330002, 11330003 |
Product
Software : myNeedle Guide 2D license, myNeedle Guide 2D AWP only Workflow license, or myNeedle Guide 3D license. Used on the following CT (Computed tomography systems): SOMATOM go.Now Model 11061610 NA* SOMATOM go.Now Model 11061618 NA* SOMATOM go.Up Model 11061620 SOMATOM go.Up Model 11061628 NA* SOMATOM go.All Model 11061630 SOMATOM go.All Model 11061638 NA* SOMATOM go.Top Model 11061640 SOMATOM go.Top Model 11061648 NA* SOMATOM X.cite Model 11330001 SOMATOME X.ceed Model 11330002 SOMATOM go.Sim Model 11061660 NA* SOMATOM go.Open Pro Model 11061670 NAEOTOM Alpha Model 11330003
Reason for recall
In the syngo.CT VA40 and syngo.CT VA50 myNeedle Guide application, the order of the orientation labels head , center, and feet in the axial thick slice segments are erroneously swapped
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-1003-2023. 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.