Philips IntelliVue Information Center Recall for Audible Alarm Loss
Philips Healthcare is recalling IntelliVue Information Center software due to a potential loss of audible alarms caused by damaged internal audio cable contacts.
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 is classified as FDA Class II and involves a risk-of-harm product (medical device alarm failure) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Philips Healthcare Inc. is recalling the Philips IntelliVue Information Center/Client and Philips IntelliVue Information Center iX software. The recall involves 3,165 units distributed nationwide in the United States and in Canada.
The recall is being issued because an internal audio cable may have diminished retention force due to damaged contacts. This defect could lead to intermittent or complete loss of audible alarms. The software is intended to display physiologic waves, parameters, and trends, and to provide secondary annunciation of alarms from other networked medical devices at a centralized location.
Healthcare facilities should contact Philips Healthcare for instructions on how to resolve the issue. The recall is classified as Class II by the FDA, indicating that the defect could cause temporary or medically reversible health consequences.
The recalled product
- Product
- 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…
- Manufacturer
- Philips Healthcare Inc.
- Hazard
- Affected units
- 3,165
Distribution
Distributed nationwide across the United States.
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