Agency classClass IIOur severity:High FDA (Devices)·Z-0856-2016·Announced 2016-03-02

Philips IntelliVue Info Center iX Software Recall for ECG Waveform Misrepresentation

Philips is recalling IntelliVue Info Center iX software because reconstructed ECG leads may misrepresent waveforms in specific leads.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device software defect that may misrepresent ECG waveforms, posing a risk of harm through diagnostic error, but no injuries or illnesses are reported in the source text.

Plain-English summary

Philips Electronics North America Corporation is recalling the Philips Healthcare IntelliVue Info Center iX, A.0 866023 software. The recall involves 5,671 units distributed worldwide, including the United States and numerous international locations. The software version is identified as A.0.X.

The recall was initiated because reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG waveform in specific leads. This defect could potentially affect the accuracy of the displayed or printed electrocardiogram data.

Healthcare facilities and users of the affected software should contact Philips for further instructions on how to address the issue. The source text does not specify a particular action for consumers, but users should verify if their systems are affected by the software version A.0.X.

The recalled product

Product: Philips Healthcare IntelliVue Info Center iX, A.0 866023
Manufacturer: Philips Electronics North America Corporation
Category: Medical Device — Cardiac Monitoring Software
Hazard: mis-labeling
diagnostic-error
Affected units: 5,671

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

Software A.0.X

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Philips Electronics North America Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Philips Electronics North America Corporation

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Same hazard · mis labeling