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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67559

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

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Event summary

Timeline bucket
January 27, 2014
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 Dynamics Picture Archiving and Communication System (PACS). Model numbers 10091804, 10091805, 10091806, 10091807, 10091673

Z-1216-2014
Recall number
Z-1216-2014
Initiated
January 27, 2014
Classification
Class II
Status
Terminated
Quantity
50

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential patient data mixup. Improper error handling could allow for two different patients to be displayed in syngo Dynamics. Images shown for one patient and reporting system shown for a different patient, leading to the potential for misdiagnosis.

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

Potential patient data mixup. Improper error handling could allow for two different patients to be displayed in syngo Dynamics. Images shown for one patient and reporting system shown for a different patient, leading to the potential for misdiagnosis.

Code information

Model nos.10091804, 10091805, 10091806, 10091807, 10091673. syngo Dynamics Version 9.5 using Sensis integration.

Distribution pattern

Nationwide distribution to MN, AR, MA, TX, NJ, WV, GA, CA, PA, OH, MI, WI, TN, NY, KS, CT, NY, MO, IL, IN, OR, IA, and WA.