Recall Z-0495-2013— Philips Healthcare Inc.
Class II · Terminated
Class II FDA medical device recall by Philips Healthcare Inc., initiated 2012-11-09. It names 2 FDA 510(k) clearances: K102495, K081983. 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: Internal audio cable may have diminished retention force due to damaged contacts, which could lead to intermittent or loss of audible alarms..
- Recalling firm
- Philips Healthcare Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-11-09
- Firm location
- Andover, MA, United States
510(k) clearances named in this recall
2 on FDA's record- K102495 — M3290B INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE A.0
- K081983 — M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE 1.00
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.