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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91481

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
December 22, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Siemens Medical Solutions USA, Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-1003-2023
Recall number
Z-1003-2023
Initiated
December 22, 2022
Classification
Class II
Status
Ongoing
Quantity
29 units U.S.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

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Inspect official wording and provenance

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

Code information

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

Distribution pattern

Nationwide