# FDA recall Z-1003-2023

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2022-12-22.

## 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

## Distribution

Nationwide

## Key facts

- **Recall number:** Z-1003-2023
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-12-22
- **Report date:** 2023-02-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Malvern, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1003-2023

## Citation

> AI Analytics. FDA recall Z-1003-2023. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-1003-2023. Source: US FDA. Licensed CC0.

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