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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 63709

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

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Event summary

Timeline bucket
November 09, 2012
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Philips Healthcare 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

Philips IntelliVue Information Center/Client and Philips IntelliVue Information Center iX The intended use of the Information Center Software is to display physiologic waves, parameters, and trends, format data for strip chart recordings and printed reports, and provide the secondary annunciation of alarms from other networked medical devices at a centralized location. The Information Center Software provides for the retrospective review of alarms, physiologic waves and parameters from its database. An additional intended use of the Information Center Software is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors.

Z-0495-2013
Recall number
Z-0495-2013
Initiated
November 09, 2012
Classification
Class II
Status
Terminated
Recalling firm
Philips Healthcare Inc.
Quantity
3165

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Internal audio cable may have diminished retention force due to damaged contacts, which could lead to intermittent or loss of audible alarms.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Internal audio cable may have diminished retention force due to damaged contacts, which could lead to intermittent or loss of audible alarms.

Code information

PIIC 865435 M3140 Information Center Low Acuity 865436 M3150 Information Center Local DB 865417 M3145 Information Center Small NW DB 865418 M3155 Information Center NW DB 865415 M3151 Information Center Client 865421  M3170 Patient Link 865416  M3177 Trend Display 865422  M3140 Upgrade 865423  M3150 Upgrade 865426  M3145 Upgrade 865427  M3155 Upgrade 865424  M3151 Upgrade 865266 - M3140 Information Center Low Acuity 865267  M3150 Information Center Local DB 865269  M3145 Information Center Small NW DB 865268  M3155 Information Center NW DB 865270  M3151 Information Center Client 865274  M3170 Patient Link 865271  M3177 Trend Display 865277  M3140 Upgrade 865278  M3150 Upgrade 865281  M3145 Upgrade 865282  M3155 Upgrade 865279  M3151 Upgrade PIIC iX 866023  IntelliVue Info Center iX 866117  PIIC Classic Upgrade 866027  PIIC iX HW Upgrade

Distribution pattern

Worldwide Distribution - USA (nationwide) and Canada.

Field note

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