Philips IntelliVue Info Center iX Recalled for ECG Waveform Misrepresentation
Philips is recalling IntelliVue Info Center iX monitors because reconstructed ECG leads may misrepresent waveforms, potentially affecting clinical interpretation.
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 where a defect could lead to misinterpretation of patient data (risk of harm), but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Philips Electronics North America Corporation is recalling 1,880 units of the IntelliVue Info Center iX, B.0, 866389 Physiological Patient Monitor. The recall involves software versions B.0.X. The devices were distributed nationwide in the United States and in numerous countries worldwide, including Canada, the United Kingdom, Germany, and Japan.
The recall is being conducted because reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG waveform in specific leads. This defect could lead to inaccurate display of patient data. The source text does not report any specific injuries, illnesses, or deaths associated with this defect.
Healthcare facilities should contact Philips for instructions on how to address the software issue. Consumers and patients should consult their healthcare providers regarding the use of these devices.
The recalled product
- Product
- Philips Healthcare IntelliVue Info Center iX, B.0, 866389 Physiological, Patient Monitor (With Arrhythmia Detection or Alarm)
- Manufacturer
- Philips Electronics North America Corporation
- Category
- Medical Device — Patient Monitor
- Affected units
- 1,880
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 Versions: B.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.
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