Z-1003-2023Class II

Software : myNeedle Guide 2D license, myNeedle Guide 2D AWP only Workflow license, or myNeedle Guide 3D...

Name: Z-1003-2023 Software : myNeedle Guide 2D license, myNeedle Guide 2D AWP only Workflow license, or myNeedle Guide 3D...
Creator: Siemens Medical Solutions USA, Inc
Published: 2022-12-22
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2022-12-22 / Open, Classified / root cause: labeling and UDI

FDA source

Siemens Medical Solutions USA, Inc began a recall of Software : myNeedle Guide 2D license, myNeedle Guide 2D AWP only Workflow license, or myNeedle Guide 3D license. Used on the following CT (Computed tomography... on 2022-12-22. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1003-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-12-22
Posted: 2023-01-20
Recalling firm: Siemens Medical Solutions USA, Inc.
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
Product code: JAK System, X-Ray, Tomography, Computed
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
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Siemens Customer Safety Advisory Notification CT083/22/S issued beginning on 12/23/2022 via email. Letter states reason for recall, health risk and action to take: When performing a CT intervention study, please make sure that the Recon parameter Image order is set to Head to Feet. Provides instruction on how to avoid the issue. Siemens is currently working on a permanent solution for this issue. This solution will be rolled out as a software update to all affected customers free of charge. Siemens is currently working on a permanent solution for this malfunction. This solution will be rolled out as a software update to your CT Scanner. The Siemens Service Organization will contact you as soon as the update is available. Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Customer Safety Advisory Notice. By signing this document, you are acknowledging that you have read and understood the content therein. Regional Contact: Name: Rebecca Tudor Department: Post Market Regulatory Compliance Telephone: (484) 323-4198 Email: [email protected]
Quantity in commerce: 29 units U.S.
Distribution: Nationwide
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1003-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1003-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-01	2023-01-20

Product code JAK

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)