Data Foundry

Medical device recalls 2012

Philips IntelliVue Information Center/Client and Philips IntelliVue… — Class II medical device recall Z-0495-2013

Terminated recall by Philips Healthcare Inc., reported 2012-12-19, distributed nationwide. Internal audio cable may have diminished retention force due to damaged contacts, which could lead to intermit

Recall numberZ-0495-2013
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmPhilips Healthcare Inc., Andover, MA, United States
Recall initiated2012-11-09
Classified2012-12-10
Reported by FDA2012-12-19
DistributedNationwide (US)
Countries outside the USCA
Quantity3,165

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 secondary annunciation of alarms from other networked medical devices at a centralized location. The Information Center Software provides for the retrospective review of alarms, physiologic waves and parameters from its database. An additional intended use of the Information Center Software is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors.

Reason for recall

Internal audio cable may have diminished retention force due to damaged contacts, which could lead to intermittent or loss of audible alarms.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0495-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.