—#197992

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

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K200524, K211373, K220814
Affected lot / code info: 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

Why it was recalled

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 (FDA determination)

Under Investigation by firm

Action the firm took

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: rebecca.tudor@siemens-healthineers.com

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern: Nationwide

Timeline

Recall initiated: 2022-12-22
Posted by FDA: 2023-01-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #197992. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.