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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92394

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

Open FDA event record

Event summary

Timeline bucket
May 22, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Covidien, LLC

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

Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS

Z-2008-2023
Recall number
Z-2008-2023
Initiated
May 22, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Covidien, LLC
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Single ILLUMISITE Platform Console was converted from a 220-240VAC model to a 120VAC configuration using a non-supplied power cord and non-supplied fuses in the field by Medtronic Field Service Engineer.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Single ILLUMISITE Platform Console was converted from a 220-240VAC model to a 120VAC configuration using a non-supplied power cord and non-supplied fuses in the field by Medtronic Field Service Engineer.

Code information

UDI-DI: 10884521782211; Serial Number: 518503

Distribution pattern

International distribution in the country of Taiwan.