Reported Feb 1, 2023 · Ongoing

Software

Siemens Medical Solutions USA, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Siemens Medical Solutions USA, Inc · 40 Liberty Blvd · Malvern, PA · 19355-1418

Is this the product you have?

Software

13 of 13 products

Products covered by this recall
Model / numberProduct as published
11061610NA* SOMATOM go.Now
11061618NA* SOMATOM go.Up
11061620SOMATOM go.Up
11061628NA* SOMATOM go.All
11061630SOMATOM go.All
11061638NA* SOMATOM go.Top
11061640SOMATOM go.Top
11061648NA* SOMATOM X.cite
11330001SOMATOME X.ceed
11330002SOMATOM go.Sim
11061660NA* SOMATOM go.Open Pro
11061670NAEOTOM Alpha
11330003
Lot codes and dates
  • UDI
    • 04056869151571
    • 04056869051314
    • 04056869151564
    • 04056869151571
    • 04056869231044 04056869231051
    • 04056869249247
    • 04056869263168
    • ¿04056869051314
  • S/NSerial 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
Amount recalled
29 units U.S.

Where it was sold

  • Nationwide

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:54 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.