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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 72720

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 25, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Philips Electronics North America Corporation

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

3 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 3

Philips Healthcare IntelliVue Info Center iX, A.0 866023

Z-0856-2016
Recall number
Z-0856-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Quantity
5671 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG waveform in specific leads.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Design Change

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG waveform in specific leads.

Code information

Software A.0.X

Distribution pattern

Worldwide Distribution-US (nationwide) and the countries of Algeria Australia Austria Belgium Bulgaria Canada Denmark Estonia Finland France Germany Hong Kong Hungary Iceland India Indonesia Iraq Ireland Israel Italy Japan Kenya Korea Kuwait Luxembourg Malaysia Mongolia Morocco Netherlands New Zealand Nigeria Norway Poland Qatar Romania Russian Federation Saudi Arabia Singapore Slovenia South Africa Spain Sweden Switzerland Taiwan Turkey United Arab Emirates and United Kingdom.

device · product 2 of 3

Philips Healthcare PIIC Classic Upgrade, 866117 Physiological, Patient Monitor (With Arrhythmia Detection or Alarm)

Z-0857-2016
Recall number
Z-0857-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Quantity
5569 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG waveform in specific leads.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Design Change

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG waveform in specific leads.

Code information

Software B.O

Distribution pattern

Worldwide Distribution-US (nationwide) and the countries of Algeria Australia Austria Belgium Bulgaria Canada Denmark Estonia Finland France Germany Hong Kong Hungary Iceland India Indonesia Iraq Ireland Israel Italy Japan Kenya Korea Kuwait Luxembourg Malaysia Mongolia Morocco Netherlands New Zealand Nigeria Norway Poland Qatar Romania Russian Federation Saudi Arabia Singapore Slovenia South Africa Spain Sweden Switzerland Taiwan Turkey United Arab Emirates and United Kingdom.

device · product 3 of 3

Philips Healthcare IntelliVue Info Center iX, B.0, 866389 Physiological, Patient Monitor (With Arrhythmia Detection or Alarm)

Z-0858-2016
Recall number
Z-0858-2016
Initiated
November 25, 2015
Classification
Class II
Status
Terminated
Quantity
1880 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG waveform in specific leads.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Design Change

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG waveform in specific leads.

Code information

Software Versions: B.0.X

Distribution pattern

Worldwide Distribution-US (nationwide) and the countries of Algeria Australia Austria Belgium Bulgaria Canada Denmark Estonia Finland France Germany Hong Kong Hungary Iceland India Indonesia Iraq Ireland Israel Italy Japan Kenya Korea Kuwait Luxembourg Malaysia Mongolia Morocco Netherlands New Zealand Nigeria Norway Poland Qatar Romania Russian Federation Saudi Arabia Singapore Slovenia South Africa Spain Sweden Switzerland Taiwan Turkey United Arab Emirates and United Kingdom.

Field note

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