CLASS II Device recall · Reported 2 Mar 2016 · FDA Enforcement Report

Philips Healthcare IntelliVue Info Center iX, B.0 recalled

Philips Electronics North America is recalling Philips Healthcare IntelliVue Info Center iX, B.0, 866389 Physiological, Patient Monitor, distributed nationwide in the US. The recall was initiated on 25 Nov 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSoftware Versions: B.0.X

Quantity recalled1880 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0858-2016
FDA event ID: 72720
Recalling firm: Philips Electronics North America, Andover, MA
Classification: Class II
Status: Terminated
Recall initiated: 25 Nov 2015
FDA classified: 23 Feb 2016
Reported: 2 Mar 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Patient Monitors

Timeline

25 Nov 2015	Recall initiated by company
23 Feb 2016	Classified by FDA	+90 days
2 Mar 2016	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

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.

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Software Versions: B.0.X

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 72720

This product is part of a recall event; the main page for the event is Philips Healthcare PIIC Classic Upgrade recalled.

Reported	Class	Recall	Company	Reason	Where
2 Mar 2016	CLASS II	Philips Healthcare PIIC Classic Upgrade recalled	Philips Electronics North America	Device Malfunction	Nationwide
2 Mar 2016	CLASS II	Philips Healthcare IntelliVue Info Center iX, A.0 recalled	Philips Electronics North America	Other	Nationwide

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