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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81797

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

Open FDA event record

Event summary

Timeline bucket
December 03, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Philips Medical Systems Nederlands

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

Ingenia Elition S, Ingenia Elition X

Z-0694-2019
Recall number
Z-0694-2019
Initiated
December 03, 2018
Classification
Class II
Status
Terminated
Quantity
35

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During automatic tabletop movement, pressing and holding the Stop Table button may lead to an unexpected restart of the table movement.

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

During automatic tabletop movement, pressing and holding the Stop Table button may lead to an unexpected restart of the table movement.

Code information

Software version R5.5.0 Serial numbers: 45027 45011 45010 45024 45032 45026 45054 45035 45051 45052 45007 45043 45044 45031 45039 45025 46001 45033 45050 45034 45049 45037 45048 46004 45046 45008 45058 45028 45029 45030 45042 46005 46011 45040 45045

Distribution pattern

CA, MN, NJ, NY, OH, TN, TX. Foreign distribution to Canada, Belgium, France, Germany, INdia, Japna, Netherlands, South Africa, Sweden, Switzerland, UAE.