Home / Recalls / Siemens Medical Solutions USA, Inc / Z-1003-2023

Z-1003-2023 Class II Ongoing

Recalled by Siemens Medical Solutions USA, Inc — Malvern, PA

FDA device recall Z-1003-2023 was initiated by Siemens Medical Solutions USA, Inc on Dec 22, 2022 and is designated Class II. 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 The recall status is ongoing. Affected quantity: 29 units U.S.

Recall Details

Product Type: Devices
Report Date: Feb 1, 2023
Initiation Date: Dec 22, 2022
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 29 units U.S.

Product Description

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 Pattern

Nationwide

Code Information

UDI: 04056869151571, 04056869051314, 04056869151564, 04056869151571, 04056869231044 04056869231051, 04056869249247, 04056869263168, ¿04056869051314 S/N: Serial Number 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 172914 172925 172949 172956

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-1003-2023
openFDA file date: Oct 21, 2026
Loaded by RegDataLab: Oct 23, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.