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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83519

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

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Event summary

Timeline bucket
July 25, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
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

syngo.CT software version VA48A_SP5.5 in the following SOMATOM computed tomography models: SOMATOM Definition Edge-Model #10590000; SOMATOM Definition AS Model #8098027; SOMATOM Definition Flash Model #10430603

Z-2440-2019
Recall number
Z-2440-2019
Initiated
July 25, 2019
Classification
Class II
Status
Terminated
Quantity
2867 units worldwide (OUS); 1464 units US

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software syngo.CT with Software version VA48A_SP5 may result in scanning workflow interruptions

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

SOMATOM Definition Edge, SOMATOM Definition AS, SOMATOM Definition Flash with software syngo.CT with Software version VA48A_SP5 may result in scanning workflow interruptions and unexpected user notifications. and may result in a delay in diagnosis and/or patient rescans

Code information

syngo.CT software version VA48A_SP5.5

Distribution pattern

Nationwide Foreign:

Field note

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