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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 73481

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

Open FDA event record

Event summary

Timeline bucket
February 24, 2016
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 X Workplace is a medical workstation for real-time viewing, image manipulation, 3D-visualization, communication, and storage of medical images and data on exchange media. It is used for diagnostic image viewing and post processing during interventional procedures. .

Z-1232-2016
Recall number
Z-1232-2016
Initiated
February 24, 2016
Classification
Class II
Status
Terminated
Quantity
6

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
After importing, the segmentation results appear mirrored at the CARTO system and can't be used for the ablation procedure.

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

After importing, the segmentation results appear mirrored at the CARTO system and can't be used for the ablation procedure.

Code information

Serial # 20119, 20098, 20041, 20124, 12177, 20026

Distribution pattern

Nationwide Distribution to IL, NY, MT, and MN.