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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76278

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

Open FDA event record

Event summary

Timeline bucket
January 11, 2017
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.plaza, picture archiving and communications system.

Z-1116-2017
Recall number
Z-1116-2017
Initiated
January 11, 2017
Classification
Class II
Status
Terminated
Quantity
62 systems

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Software update for improvements and to resolve several issues

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.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Software update for improvements and to resolve several issues

Code information

Model Number: 10863171, 10863172, 10863173 Serial Numbers: 100262 100198 100258 100259 100135 100538 100133 100031 100105 100106 100109 100110 100111 100112 100113 100114 100115 100116 100117 100119 100120 100416 100461 100245 100447 100364 100298 100299 100386 100139 100027 100440 100441 100559 100025 100033 100196 100189 100190 100191 100192 100195 100186 100232 100450 100449 100256 100199 100188 100194 100198 100029 100253 100203 100204 100132 100139 100434 100476 100495 100491 100206

Distribution pattern

Distributed throughout the United States.