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Software recallZ-1003-2023 · Siemens Medical Solutions USA, Inc · initiated Dec 22, 2022

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Siemens Medical Solutions USA, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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

FDA root cause category: Under Investigation by firm

What the company is doing

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]

Recall details

Recall number
Z-1003-2023
Status
Open, Classified
Initiated by the company
Dec 22, 2022
Posted by the FDA
Jan 20, 2023
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
29 units U.S.
Product code
JAK
FDA submissions
K200524, K211373, K220814
Distribution
Nationwide

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

Code information (models, lots, serial numbers)

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

Devices named in this recall

6 devices in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

2 devices cleared under K200524, K211373, K220814 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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