CLASS II ONGOING Device recall · Reported 1 Feb 2023 · FDA Enforcement Report

Software : myNeedle Guide 2D license, myNeedle Guide 2D AWP only recalled

Siemens Medical Solutions USA is recalling Software : myNeedle Guide 2D license, myNeedle Guide 2D AWP only, distributed nationwide in the US. The recall was initiated on 22 Dec 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: 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

Quantity recalled29 units U.S.

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1003-2023
FDA event ID: 91481
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Ongoing
Recall initiated: 22 Dec 2022
FDA classified: 20 Jan 2023
Reported: 1 Feb 2023
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Device Malfunction
Device type: Syringes & Needles

Timeline

22 Dec 2022	Recall initiated by company
20 Jan 2023	Classified by FDA	+29 days
1 Feb 2023	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

Nationwide

Questions about this recall

Is Software : myNeedle Guide 2D license, myNeedle Guide 2D AWP only recalled?

Yes. Siemens Medical Solutions USA recalled Software : myNeedle Guide 2D license, myNeedle Guide 2D AWP only on 22 Dec 2022. The recall is Class II and its status is Ongoing. Recall number Z-1003-2023.

Why was it 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

Which lots are affected?

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

Where was it sold?

Nationwide

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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