Company:Philips Healthcare Inc.
Date of Enforcement Report 7/6/2011
Class ll:
PRODUCT
Philips Audio-Video Engineering PAS-210 Remote Active Speakers Kit used with the IntelliVue Information Center The intended use of the Information Center Software is to display physiologic waves, parameters and trends, formal data for strip 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 is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors. Software Releases A, B, C, D.0, D.01, E.0, E.01, F.0, G, H, J, K, L, & M of Philips IntelliVue Information Center Software used in conjunction with PAS-210 Kit Remote Active Speakers. Recall # Z-2217-2011
REASON
PAS-210 Kit Remote Active Speaker Assembly used with the IntelliVue Information CenterSpeaker cable connection may lead to intermittent or loss of audio alarm annunciation.
RECALLING FIRM/MANUFACTURER
Philips Healthcare Inc., Andover, MA, by letter dated April 28, 2011. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
15,062 units
DISTRIBUTION
Nationwide and Canada
