Agency classClass IIOur severity:High FDA (Devices)·Z-1003-2023·Announced 2023-02-01

Siemens myNeedle Guide Software: Swapped Orientation Labels in CT Systems

Siemens myNeedle Guide software for CT imaging systems has swapped orientation labels in axial images, which could lead to misorientation during guided procedures. The software requires correction.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device software with swapped orientation labels presents a risk of diagnostic error in CT-guided procedures. No illnesses or injuries have been reported, meeting the rubric criterion for risk-of-harm products without reported injury.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling myNeedle Guide software (2D and 3D licenses) used with multiple CT imaging systems including SOMATOM go.Now, go.Up, go.All, go.Top, X.cite, X.ceed, go.Sim, go.Open Pro, and NAEOTOM Alpha models.

In the syngo.CT VA40 and VA50 myNeedle Guide application, the orientation labels 'head,' 'center,' and 'feet' are displayed in the wrong order within axial thick slice segments. This labeling error could cause confusion during needle guidance procedures, potentially leading to misorientation or diagnostic errors.

The recalled software affects 29 units distributed nationwide to medical facilities using the affected Siemens CT systems.

Healthcare providers using affected equipment should contact Siemens Medical Solutions USA, Inc. for a software correction to restore accurate orientation labeling.

The recalled product

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…
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Imaging Software
Hazard: mis-labeling
orientation-error
Affected units: 29

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (7)

UDI: 04056869151571
04056869051314
04056869151564
04056869151571
04056869231044 04056869231051
04056869249247
04056869263168

Distribution

Distributed nationwide across the United States.

Same manufacturer · Siemens Medical Solutions USA, Inc

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